Startseite Patient-reported pain, satisfaction, adverse effects, and deviations from ambulatory surgery pain medication
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Patient-reported pain, satisfaction, adverse effects, and deviations from ambulatory surgery pain medication

  • Iiris Särkilahti , Elina Reponen und Noora Skants EMAIL logo
Veröffentlicht/Copyright: 6. Juni 2024
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Abstract

Objectives

Addressing the challenges of ambulatory surgery involves balancing effective pain relief with minimizing the side effects of pain medication. Due to the heightened risk of opioid abuse, Helsinki University Hospital (Finland) has had a stringent oxycodone prescription policy. This policy prompts an exploration into whether ambulatory surgery patients experience severe post-surgical pain and whether an increase in prescribed opioids would cause elevation in adverse effects.

Methods

This prospective cohort study, with a 1-week follow-up, included 111 adult ambulatory surgery patients (orthopaedics, urology). The patients documented their pain levels within the first postoperative week (using a numerical rating scale [NRS] of 0–10) and pain medication intake up to two days postoperatively. Furthermore, they completed a questionnaire assessing their satisfaction with pain relief, medication-related adverse effects, and adherence to instructions. Medication intake was cross-referenced with the provided instructions and prescriptions.

Results

A notable 56% of patients reported experiencing intense pain (NRS ≥5) within a week following surgery. Of these, 52% received a single dose of slow-release oxycodone (5–20 mg) at discharge for use on the night of surgery. Predominantly prescribed pain medications included a combination of paracetamol and codeine (64%) or ibuprofen (62%). Satisfaction rates were high, with 87% expressing satisfaction with pain medication given at hospital discharge and 90% expressing contentment with the prescribed medication. The most common adverse effects were tiredness/grogginess (45%), sleep disturbances (38%), nausea (37%), and constipation (27%). Also, 24% of patients self-reported deviations from medication instructions. A comparison of self-reported and instructed medications revealed that 14% exceeded prescribed dosages, and 28% opted for preparations different from those prescribed. Notably, patients who self-reported deviations from instructions differed from those objectively deviating from instructions.

Conclusions

Although 56% of patients had intense pain, the majority expressed satisfaction with the provided pain relief. Instances of non-adherence to medication instructions were prevalent, often going unnoticed by the patients themselves.

1 Introduction

Ambulatory surgery, also known as day surgery, proves to be cost-effective and reduces the demand on hospital resources. Studies indicate its safety and potential to decrease morbidity [1,2]. However, challenges in ambulatory surgery include effectively informing patients about postoperative care and ensuring adequate pain relief after discharge [3,4]. For instance, in ambulatory foot surgery, 9% of patients reported experiencing extreme pain (numerical rating scale [NRS] ≥8/10) following discharge [4].

There is a wide variation in prescribing pain medication, including opioids, for common general surgery procedures, with instances of excessively prescribed opioid dosages in many cases [5,6]. In the United States, prescription-involved opioid overdose deaths increased from under 4,000 deaths in 1999 to 15,000 deaths in 2018 [7]. Given the potential for opioid abuse, physicians are urged to strike a balance between ensuring adequate pain management and considering the optimal dosage, duration, and potential adverse effects of opioid treatment [8].

At Helsinki University Hospital (HUH) in Helsinki, Finland, we have a stringent oxycodone prescription policy compared to the clinic average in international reports [5,6]. Specifically, in the HUH Peijas Hospital ambulatory surgery department, oxycodone is not prescribed. Instead, patients are provided with 1–2 oxycodone 5–10 mg tablets at discharge, intended for use on the night of surgery. A combination of paracetamol and codeine or tramadol may be prescribed for patients undergoing painful orthopaedic operations surgery. This has raised the question of whether our patients suffer from severe post-surgical pain. If we increase the prescribed amount of oxycodone, it may increase serious opioid adverse effects (e.g. drowsiness predicting apnoea, dizziness predicting falling), medication errors, and oxycodone abuse.

In this prospective questionnaire-based follow-up study, we aimed to assess whether our patients experienced severe pain, determine the adequacy of pain medication, identify any pain medication-related adverse effects, and ascertain instances of patients deviating from pain medication instructions.

2 Methods

2.1 Study setting

In this prospective, questionnaire-based, cohort study setting with a one-week follow-up, we collected a consecutive series of patients undergoing ambulatory surgery at Helsinki University Hospital, Peijas Hospital (Hospital District of Helsinki and Uusimaa HUS, Finland), from 1 April 2017 to 30 June 2017. The original study plan was registered with ClinicalTrials.gov (ref. NCT03135470).

2.2 Study population

All adult patients aged 18 years and older, scheduled for elective ambulatory surgery during the study period, were eligible to participate in the study. Ambulatory surgery, for the purpose of this study, was defined as a surgical procedure requiring general anaesthesia or major regional anaesthesia performed in an operating room (OR) on a patient who arrived at the hospital and was discharged on the same day of the index operation surgical procedure (prior to the closure of the ambulatory surgery department at 6:30 pm). Orthopaedic surgeries included, e.g. foot-and-ankle surgery, arthroscopic knee and shoulder surgery, and the removal of osteosynthesis material. Urological procedures encompassed, e.g. circumcision, excisions of hydrocele or spermatocele, bladder hydrodistension, and visual laser resection of the prostate.

Exclusion criteria included an inability to understand the written study information (e.g. lack of fluency in Finnish or Swedish, the official languages in Finland), age below 18 years, pregnancy, guardianship status, active military conscription, or incarceration. In the case of multiple surgeries, a patient was enrolled only once during the study period in conjunction with the first operation surgery.

2.3 Study protocol and data collection

In brief, the study had no impact on the overall treatment protocol. Preoperative outpatient clinic visits and consultations adhered to the department’s standard practices. Premedication involved administering 1 g of paracetamol to all patients upon arrival at the day surgery department, unless contraindicated due to allergies or other medical reasons. If undergoing an orthopaedic procedure involving bone and major joints, the patients also received 5 mg (weight less than 60 kg) or 10 mg (weight 60 kg or over) of slow-release oxycodone. Patients were instructed to continue regularly used pain medication until the day of surgery (excluding the morning of the surgery). The processes of anaesthesia, surgery, postoperative care in the OR department, and postoperative pain management followed normal routines and protocols. The multimodal analgesia included peripheral regional anaesthesia when suitable, paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) if not contraindicated, small doses of immediate-release oxycodone on demand at post-anaesthesia care unit, 1–2 doses of controlled-release (CR) oxycodone upon discharge to be taken on the night of surgery and a prescription of either the combination of paracetamol and codeine or tramadol if intense pain was expected after discharge. Surgeons were responsible for prescribing medications to be collected from the pharmacy after surgery.

Demographic data were collected, including information on patients’ sex, age, weight, and height. Furthermore, we documented the surgical procedural code according to the Finnish version of the NOMESCO Nordic Classification of Surgical Procedures (Nordic Medico-Statistical Committee, Nordic Centre for Classifications in Health Care, Orlo, Norway).

A postoperative questionnaire was employed to collect information on patient-reported pain, pain-related symptoms, and treatment during the first postoperative week (Table S1, Supplementary Material). The study patients were asked to report all pain medications taken up to 2 days postoperatively. Additional pain and pain-medication-related questions included the intensity of the pain (measured on an NRS from 0 to 10, where 0 indicates no pain and 10 reflects the worst pain imaginable), the intensity of nausea (NRS 0 to 10, where 0 indicates no nausea and 10 signifies extremely intense nausea), and other common side effects such as vomiting, constipation, dizziness, abdominal pain or gastroesophageal reflux, confusion, hallucinations, delusions, tiredness, fatigue, grogginess, respiratory arrest, snoring, or worsening obstructive sleep apnoea. Furthermore, the patients were asked to report whether they had contacted any healthcare facility or professional regarding pain, experienced pain-medication-related issues in the first postoperative week, deviated from the prescribed pain medication regimen, used non-medical pain relief methods such as cold or elevation of the operated extremity, or suffered from pain-related sleep disturbances. The patients reported the adequacy of pain medication provided by the hospital and prescribed by the surgeon, the cost of prescribed pain medication, and the adequacy of information on pain relief given prior to discharge. Finally, the patients expressed their satisfaction with postoperative pain management in general and were given the opportunity to provide comments or feedback to the hospital.

Data from hospital databases were extracted for analysis. In our department, all medical information during the hospital stay is routinely recorded into electronic patient records and a national electronic prescription database. This enabled us to retrieve data on postoperative pain medications, prescriptions, and any recorded postoperative complications.

2.4 Endpoints

Our primary endpoint was patients’ answers to the question “Please rate the most intensive pain you have experienced within the first postoperative week on a scale of 0 to 10 (0 = no pain, 10 = worst imaginable pain)” (Table S1, Supplementary Material). The other endpoints were pain levels on the day of surgery (day 0), the first postoperative day (day 1), and the second postoperative day (day 2). We also assessed medications given and prescribed, self-reported medication intake by the patient (days 0–2), satisfaction with pain management (NRS 0–10; 0 = very unsatisfied, 10 = extremely satisfied), patient-reported adequacy of medication given at discharge (yes/no) or prescribed (yes/no), adequacy of medication instructions (yes/no), most intensive experienced nausea (NRS 0–10; also presented as dichotomous 0 = no, 1–10 = yes), experienced adverse effects (yes/no), self-reported deviations from instructions (yes/no, from the questionnaire), and researcher-observed deviations.

Patients who self-reported deviations were divided into three categories: (1) patients who took less medication than instructed, (2) patients who took more medication than instructed, and (3) patients who changed the products they used.

The researcher-observed deviations were determined by comparing self-reported medication use with data from electronic patient records and the national electronic prescription database. Instances of taking a non-prescribed drug or exceeding prescribed doses were considered researcher-observed deviations. In contrast, taking lower doses or discontinuing the medication earlier than instructed were not classified as researcher-observed deviations. Notably, a change in the product to a contraindicated one or exceeding the maximal recommended daily doses was considered a major risk.

2.5 Statistical analyses

Continuous parametric variables are presented as means with standard deviations (SD), while categorical variables are expressed as frequencies and percentages. For patient demographics, minimum and maximum values and the calculated body mass index are also provided, and, for pain, median values are reported. A two-sided t-test was used to test differences in maximal experienced pain in relation to the presence or absence of sleep disturbances. The Mann–Whitney U test was used to examine differences in nausea (NRS 0–10) between oxycodone and any opioid intake groups. Comparisons between two dichotomous variables were conducted using the Pearson chi-squared test. In cases with an expected cell count of <5, Fisher’s exact test was applied. P-values <0.05 were considered statistically significant. The statistical analyses were performed using IBM SPSS version 25 (International Business Machines Corporation, Armonk, New York).

3 Results

3.1 Patients and surgical procedures

In total, 562 patients underwent ambulatory surgery in our hospital during the study period. The final cohort included 111 patients, with a predominant representation of females (66.7%) and a median age of 55 (range 18–82) years (Table 1). Most of the study participants underwent orthopaedic surgery, accounting for 88% of the cases (98 patients). The classes of surgical procedures are presented in Table S2 (Supplementary Material).

Table 1

Patient characteristics

n (%) Mean (SD) Min, max
Male 37 (33.3)
Female 74 (66.7)
Age (years) 111 53.0 (14.2) 18, 82
Height (m) 110 1.70 (0.10) 1.50, 2.04
Weight (kg) 110 75.2 (13.7) 49, 115
BMI (kg/m2) 110 26.0 (3.9) 18.0, 36.2

BMI, body mass index; max, maximum; min, minimum; n, number of persons; SD, standard deviation.

3.2 Pain

The results of our primary endpoint, patients’ answers to the question “Please rate the most intensive pain you have experienced within the first postoperative week on a scale of 0 to 10 (0 = no pain, 10 = worst imaginable pain)”, are shown in Figure 1. The patients’ ratings of postoperative pain at the day of surgery (day 0), first postoperative day (day 1), and second postoperative day (day 2) are also shown in Figure 1.

Figure 1 
                  Patients’ answers to postoperative pain at the day of surgery (day 0), first postoperative day (day 1), and second postoperative day (day 2) and to the question “Please rate the most intensive pain you have experienced within the first postoperative week” (week) on a NRS of 0 to 10 (0 = no pain, 10 = worst pain imaginable)”. Box, interquartile range; asterisk, median; upper whisker, maximum; lower whisker, minimum; dot, outlier.
Figure 1

Patients’ answers to postoperative pain at the day of surgery (day 0), first postoperative day (day 1), and second postoperative day (day 2) and to the question “Please rate the most intensive pain you have experienced within the first postoperative week” (week) on a NRS of 0 to 10 (0 = no pain, 10 = worst pain imaginable)”. Box, interquartile range; asterisk, median; upper whisker, maximum; lower whisker, minimum; dot, outlier.

Within a week after orthopaedic surgery, 83% (81/98) of the patients reported pain levels of NRS ≥ 3, 61.2% (60/98) reported NRS ≥ 5, 41.8% (41/98) reported NRS ≥7, and 12.2% (12/98) reported NRS ≥9. After urological surgery, 61.5% (8/13) experienced pain levels of NRS ≥3. Two urological patients (15.3%) reported pain levels of NRS ≥5, and both reported their maximal pain as NRS 9.

3.3 Postoperative pain medication

The summary of pain medications given from the hospital by discharge, prescribed by the surgeon, and reported taken by the patients after discharge is presented in Table 2. Out of the total, 58 patients (52.3%) were given 1–2 doses of CR oxycodone upon discharge to be taken on the night of surgery. A total of 55 patients received oxycodone 10 mg, 1 patient 5 mg, 1 patient 15 mg, and 1 patient 20 mg.

Table 2

Patient cases with pain medications dispensed from hospital at discharge, prescribed by the surgeon, and reported taken postoperatively by the patients

Urological patients (%, n = 13) Orthopaedic patients (%, n = 98)
Medication dispenced from the hospital
Paracetamol 0 (0) 9 (9.2)
Ibuprofen 0 (0) 10 (10.2)
Naproxen/naproxen with esomeprazol 0 (0) 0 (0)
Other NSAIDs 0 (0) 0 (0)
Oxycodone 0 (0) 58 (59.2)
Paracetamol with codeine 0 (0) 1 (1.0)
Tramadol 0 (0) 0 (0)
Other 0 (0) 1 (1.0)
Medication prescribed
Paracetamol 8 (61.5) 13 (13.3)
Ibuprofen 8 (61.5) 61 (62.2)
Naproxen/naproxen with esomeprazol 0 (0) 14 (14.3)
Other NSAIDs 0 (0) 4 (4.1)
Oxycodone 0 (0) 0 (0)
Paracetamol with codeine 2 (15.4) 69 (70.4)
Tramadol 1 (7.1) 9 (9.2)
Other 0 (0) 0 (0)
Medication taken
Paracetamol 10 (77.0) 40 (40.8)
Ibuprofen 8 (61.5) 70 (71.4)
Naproxen/naproxen with esomeprazol 0 (0) 11 (11.2)
Other NSAIDs 0 (0) 8 (8.2)
Oxycodone 0 (0) 54 (55.1)
Paracetamol with codeine 1 (7.1) 55 (56.1)
Tramadol 1 (7.1) 7 (7.1)
Other 0 (0) 4 (4.1)

Abbreviation: NSAID, non-steroidal anti-inflammatory drug.

The mean of reported satisfaction with pain management was NRS 9.1 (SD 1.6; Table 3). Most orthopaedic patients (89.7%, 87/97) and all urological patients expressed satisfaction with pain management in the range of NRS 8–10.

Table 3

Satisfaction in pain management by NRS; (0 = very unsatisfied, 10 = extremely satisfied) among answered patients

Satisfaction in pain management Urological patients (n = 13) Orthopaedic patients (n = 97)
Mean 9.6 9.0
Median 10 10
SD 0.7 1.7
Min 8 2
Max 10 10

Abbreviations: Max, Maximum; min, minimum; SD, standard deviation.

Most orthopaedic patients (85.1%, 74/87) and all urological patients reported that the pain medication provided by the hospital at discharge was adequate. The medication prescribed by the surgeon was reported adequate by 91.3% (84/92) of orthopaedic patients and 83.3% (10/12) of urological patients. Instructions on pain management were considered adequate by 91.4% (85/93) of orthopaedic patients and by all urological patients.

3.4 Adverse effects

In total, 59.5% (66/111) of the patients reported one or multiple adverse effects (Table 4). The mean of reported most intensive nausea experienced within the first postoperative week was NRS 1.6 (SD 2.9). The most common adverse effects were tiredness/fatigue/grogginess (44.9%, 48/107), sleep disturbances (37.5%, 39/104), nausea (36.9%, 41/111), and constipation (26.9%, 28/104). Despite nausea, only 3.8% (4/105) reported vomiting. More serious adverse events, such as confusion/hallucinations/delusions and respiratory arrest/snoring/worsening of sleep apnoea, were 4.8% and 5.9%, respectively. Patients utilizing any postoperative opioid had a higher incidence of adverse effects in general, as well as tiredness/fatigue/grogginess and constipation, than patients without opioid use (Table 4). Patients with sleep disturbances had more pain (NRS 6.8; SD 2.1, P < 0.001, t-test) than patients without sleep disturbances (4.4; 2.5). The most intensive experienced nausea did neither differ between the patients with or without oxycodone use nor with or without any opioid use (Mann–Whitney U-tests non-significant [NS]). There was no correlation between experienced nausea (NRS 0 = no/NRS 1–10 = yes) and oxycodone use or any opioid use (Pearson chi-squared tests NS).

Table 4

Proportion of patients experiencing adverse effects among all respondents, and non-opioid or opioid users

All n (%) No opioid n (%) Any opioid n (%) P
Any adverse effect 66/111 (59.5) 14/33 (42.4) 52/78 (66.7) 0.017
Nausea 41/111 (36.9) 8/33 (24.2) 33/78 (42.3)
Vomiting 4/105 (3.8) 2/30 (6.7) 2/75 (2.7)
Constipation 28/104 (26.9) 4/30 (13.3) 24/74 (32.4) 0.047
Dizziness 17/105 (16.2) 2/30 (6.7) 15/75 (20.0)
Abdominal pain, reflux 17/104 (16.3) 2/30 (6.7) 15/74 (20.3)
Confusion, hallucinations, delusions 5/105 (4.8) 0/30 (0) 5/75 (6.7)
Tiredness, fatigue, grogginess 48/107 (44.9) 8/32 (25.0) 40/75 (53.3) 0.007
Respiratory arrest, snoring, worsening sleep apnoea 6/102 (5.9) 1/30 (3.3) 5/72 (6.9)
Sleep disturbances 39/104 (37.5) 7/30 (23.3) 32/74 (43.2) 0.057
Other: headache 4/111 (3.6) 0/33 (0) 4/78 (5.1)

P denotes the P-values of statistically significant results from Pearson chi-squared tests.

3.5 Deviations from pain medication instructions

One-fourth (26/108, 24.1%) of study patients reported deviations from the postoperative medication instructions. Among these, 16.7% (18/108) reported a lower-than-instructed dose or earlier discontinuation, 1.9% (2/108) reported a higher dose, and 5.6% (6/108) reported a change in the pain medication product. When comparing the given and prescribed medications from electronic patient records and the national electronic prescription database with the patient-reported intake of the drugs, a deviation from the given instructions was observed in 32.7% (35/107) of cases. The product was changed by 28.3% (30/106), and the dose was exceeded by 14% (15/107) of the patients. Notably, two patients (1.9%) had a harmful combination of two different NSAID products, and seven (6.5%) clearly exceeded the instructed maximal doses of NSAIDs. The Pearson chi-squared test showed no correlation between the self-reported and observed deviations from the instructions (P = 0.55).

4 Discussion

In this cohort of ambulatory surgery patients, orthopaedic patients reported notable most intensive pain experienced within the first postoperative week (NRS mean 5.5, median 6, SD 2.6). The reported postoperative pain levels at the day of operation surgery and the first and second postoperative days showed that the pain was strongest at the day of operation surgery and on the first postoperative day, and likely alleviated thereafter. The most intensive pain experienced within the first postoperative week of urology patients appeared milder than that of orthopaedic patients, but the small number of urology patients makes these results difficult to interpret. Despite the considerable postoperative pain, particularly among orthopaedic surgical patients, approximately 90% expressed satisfaction with the prescribed pain medications and overall pain management.

Nearly 60% of the patients encountered adverse effects. The most prevalent adverse effects included tiredness (tiredness/fatigue/grogginess; 44.9%), sleep disturbances (37.5%), nausea (36.9%), and constipation (26.9%). Serious adverse events, such as hallucinations and respiratory arrest, were relatively common for day surgery patients (4.8 and 5.9%, respectively). Respiratory side effects (snoring, worsening of sleep apnoea, or respiratory arrest) were reported in 5.9% (6/105) of study participants. Five out of six people experiencing these side effects were taking opioid medication and 4/6 were given a single dose of oxycodone to use on the night of surgery. More study needs to be done to evaluate these side effects as respiratory symptoms are one of the most feared side effects of opioid use.

Consistent with our results, a review by Wu et al. [9] reported that 42% of ambulatory surgery patients experienced drowsiness, with a range of 11–62% across the studies included in the review. Tiredness was more common among patients who received oxycodone (61.5%) and those who used any opioid postoperatively (53%). The use of tramadol is associated with a high prevalence of adverse effects [10], with 69% of patients experiencing drowsiness and 40% reporting dizziness on the day of surgery [11].

Constipation is a prevalent adverse effect associated with opioid use, with estimates indicating that 40–80% of opioid users may experience opioid-induced constipation [12]. Opioid use also increases the risk of postoperative ileus [13]. The incidence of postoperative ileus in orthopaedic surgery is estimated to range between 1.6 and 3.0% [14,15].

Previous studies suggest that sleep disturbances are common in ambulatory surgery, with 40.8% of individuals awakening from sleep due to pain [16]. Our findings reveal that 37.5% (39/104) of our patients had sleep disturbances and 25 of these were given oxycodone upon discharge. Patients with sleep disturbances statistically reported higher levels of pain and it is plausible that those experiencing sleep disturbances underwent more painful procedures, leading them to be given oxycodone upon discharge. However, it remains unknown whether these patients took or were prescribed an adequate amount of pain medication.

Confusion/hallucinations/delusion were reported in 4,8% (5/105) of study patients. All patients experiencing this side effect had opioid medication. In French Pharmacovigilance Database study, hallucinations were reported in 5% of tramadol users and 3,6% of morphine users [17]. Opioid induced hallucinations are most associated with morphine use, but other opioids as fentanyl have been reported to cause them as well [18]. Oxycodone is not as usually linked to hallucinations. Many studies and case reports report hallucinations in patients receiving morphine but those patients did not have hallucinations when medication was switched to oxycodone [19,20,21].

Codeine and tramadol are prodrugs that metabolize via CYP2D6 enzyme, codeine to morphine and tramadol to O-desmethyltramadol [22]. CYP26D polymorphism affects the rate of conversion in humans [22]. In the Finnish population, around 7% of people have ultra-rapid metabolizers (UM) and 2–3% poor metabolizers (PM) of CYP2D6 [23]. UMs of CYP2D6 have been reported to have severe side effects such as respiratory depression or extensive sedation in standard dosing [22]. Finnish people have a higher frequency of UM genotype and a lower frequency of PM genotype compared to other northern European populations [23]. This raises the question whether extensive use of codeine or tramadol as first-line drugs to use after surgery is safe as 7% of Finnish people are at risk of serious side effects even in normal dosing.

One option is to change treatment protocols from codeine and tramadol to oxycodone. Of course, pain treatment with opioids comes with the concern of drug abuse. The three most abused opioids in Finland are buprenorphine, tramadol, and codeine [24]. In Finland, 94% of patients initiate opioid use with codeine or tramadol, and 20% of new opioid initiations are for post-surgical pain [25]. The prescription of paracetamol–codeine combination has been a subject of discussion in Finland and reduction in the prescription has been seen when physicians have been encouraged to prescribe smaller packages [26]. The number of oxycodone prescriptions is also rising in Finland and abuse of oxycodone seems to be increasing [25]. CR oxycodone and naloxone tablets were originally developed to prevent opioid-induced constipation [27]. Recent studies have suggested that using CR oxycodone-naloxone instead of pure CR oxycodone tablets will reduce the potential for abusing the drug intravenously as the naloxone antagonizes the opioid effect if used intravenously [28]. However, this only reduces the potential to use medication intravenously and does not affect the potential to abuse the drug orally.

Adherence to long-term medication regimens is variable but is estimated to be around 50% in developed countries [29]. For ambulatory surgery, adherence to premedication instructions varies from 60 to 90% [30,31]. For ambulatory knee and shoulder arthroscopy, Mendes Porto et al. [32] reported adherence to postoperative medication as 58%. In the case of ambulatory shoulder surgery [6], one-third of the prescribed opioid tablets remained unused, and patients lacked information regarding proper tablet disposal. In relation to common surgical procedures, 19.1% of patients receive at least one refill prescription for their postoperative opioid medication [8].

In our study, the observed deviation from postoperative medical instructions was 32.7%. Notably, 15% of patients surpassed the instructed dosage, and 6.5% of patients exceeded the dose significantly, posing a major risk to the patient. Among the 35 patients with researcher-observed non-compliance, only 10 (28.6%) acknowledged their deviation in self-reports. Conversely, out of 26 patients who self-reported deviations, 16 (61.5%) showed no researcher-observed deviations. Booysen et al. [16] reported a strong association between self-reported and observed non-compliance in day surgery patients and they suggested that either of them could be used to evaluate patient’s adherence. Interestingly, our study revealed no correlation between observed and self-reported adherence, suggesting that patients who follow instructions diligently tend to underestimate their adherence to medications, while those not adhering to instructions often fail to recognize their deviation from the given instructions. Our findings do not support the idea to use patient-reported adherence as the only tool to measure medication adherence.

Many previous studies on adherence to postoperative pain medications fail to specify whether non-adherence involves overuse or underuse of medications, and they do not draw comparisons between observed and reported adherence [31,33,34,35]. Similar trends in adherence are observed in studies of patients with chronic illnesses. For instance, among diabetic patients who self-reported adherence to their medication, 11.8% exhibited non-adherence in direct observation. Furthermore, 65% of patients reporting non-adherence were assessed as adherent [36].

As a major limitation, our original study plan included two additional three-month cohorts. Approximately 500 patients were anticipated to be treated. However, major organizational challenges led to a failure to achieve the anticipated sample size. As a result, further phases of the study were withheld. As a further limitation, our study questionnaire asked for pain on the day of surgery, on the first and second postoperative days, and maximal experienced pain within a week postoperatively but did not distinguish between pain at rest and pain during movement, making the pain results difficult to interpret and to compare with the results of other studies. Despite these significant limitations, the study’s strength lies in the prospective and systematically collected patient-reported data, offering new insights into patients’ ability to follow pain medication instructions after ambulatory surgery. Our results indicate the need for further research to optimize our ambulatory surgery pain protocol to alleviate patients’ severe pain without increasing adverse effects, compromising patient safety, or contributing to opioid abuse. This study serves as a pilot, laying the groundwork for determining the best practices in pain medication for ambulatory patients in our clinic.

In summary, the results of this pilot study showed that, most orthopaedic day surgery patients experienced severe pain within the first postoperative week. Despite the pain most patients were satisfied with their pain medication. Tiredness and constipation emerged as common adverse effects, particularly linked to the use of opioids in postoperative care. The study also highlighted challenges among patients in recognizing deviations from pain medication instructions and prescriptions. This difficulty in recognition poses a potential risk of adverse effects, especially if there is an increase in the prescribed amount of opioids.


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Acknowledgements

We extend our sincere gratitude to the personnel of the Helsinki University Hospital, Peijas Hospital ambulatory surgery department personnel, as well as all the study participants for their invaluable contributions to this research. We thank Adjunct Professor Anne Vakkuri, for her guidance and unwavering support. We also acknowledge Scribendi Inc. (Chatham, Canada) for their language editing assistance, and Arijukka Turtiainen for his invaluable help with the graphic design.

  1. Research ethics: The research involving human subjects complied with all relevant national regulations and institutional policies, in accordance with the tenets of the Helsinki Declaration (as amended in 2013). This study has received approval from the Helsinki University Hospital Operative (Surgical) Ethical Committee (Decision number HUS/485/2017). The original study plan was registered with ClinicalTrials.gov (ref. NCT03135470).

  2. Informed consent: Informed consent has been obtained from all individuals included in this study.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and have given their approval for its submission. NS and ER were responsible for study planning and data collection. IS, ER, and NS conducted the analysis and reported the results.

  4. Competing interests: The authors state no conflict of interest.

  5. Research funding: None declared.

  6. Data availability: The raw data can be obtained on request from the corresponding author.

  7. Artificial intelligence/ Machine learning tools: Not applicable.

  8. Summary of the study’s contribution to the scientific field (SMS): Day surgery patients experienced notable pain postoperatively. Opioid use correlated with common adverse events. The patients exhibited difficulty recognizing deviations from medication instructions.

  9. Summary of how the study’s findings relate to previous research (SMS): Postoperative pain of orthopaedic day surgery patients was intense despite opioid use. Potentially severe adverse events and deviations from medication instructions were common.

  10. Disclosure of previous publication or parallel submission: The data have not been published or submitted for publication in another journal.

  11. Previous presentations of the data: Skants N, Reponen E. Patient-reported sufficiency, adherence to, and adverse effects of ambulatory surgery pain medication. Congress abstract presented at 2nd IAAS European Congress on Ambulatory Surgery, Budapest, Hungary, June 10–12, 2018.

  12. Supplementary Material: This article contains supplementary material (followed by the link to the article online).

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Received: 2023-11-16
Revised: 2024-04-30
Accepted: 2024-05-13
Published Online: 2024-06-06

© 2024 the author(s), published by De Gruyter

This work is licensed under the Creative Commons Attribution 4.0 International License.

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Heruntergeladen am 11.9.2025 von https://www.degruyterbrill.com/document/doi/10.1515/sjpain-2023-0133/html
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