Data in Brief of: Liberal vs. Restricted Opioid Prescribing Following Midurethral Sling
Description
The objective was to evaluate pain control, satisfaction with pain control, and opioid utilization among patients undergoing isolated mid-urethral sling (MUS) randomized to one of two different opioid prescribing regimens. The primary outcome was average postoperative day 1 pain score and an a priori determined margin of non-inferiority was set at 2 points. 82 participants underwent isolated MUS placement and met inclusion criteria; 40 were randomized to the standard arm and 42 to the restricted group. With respect to the primary outcome of average post-operative day 1 pain score, the restricted arm (mean pain score 3.9±2.4) was non-inferior to the standard arm (mean pain score 3.7±2.7) [difference in means 0.23; 95% CI (-∞, 1.34)]. In the standard arm, 23 participants (57.5%) filled an opioid prescription compared to 8 participants (19.0%) in the restricted arm (p<0.001). 18 out of 82 participants (22.0%) utilized opioids in the 7 day post-operative period, with 10 standard (25.0%) and 8 restricted (19.0%) participants using opioids (p=0.52). Of participants using opioids, the average number of tablets used was 3.4±2.3 and only 3 participants using 5 tablets or more. On a scale of 1=”prescribed far more opioid than needed” to 5=”prescribed far less opioid than needed”, the standard arm mean was 1.9±1.0 compared to a mean of 2.7±1.0 for the restricted arm (p<0.001). Restricted opioid prescription is non-inferior to standard opioid prescription in the setting of pain control and satisfaction with pain control after isolated mid-urethral placement. Participants in the restricted arm filled fewer opioid prescriptions. On average only 3.4 tablets were used by those that filled prescriptions in both groups. Restrictive opioid prescribing practices may reduce unused opioids in the community, while achieving similar pain control.
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Women undergoing isolated MUS by a Urogynecology staff physician at a Penn State Health hospital from June 1, 2020 to November 22, 2021 were eligible. Patients who were pregnant, nursing, cognitively impaired, currently using daily opioid or with opioid use disorder, allergic to study opioid (oxycodone) or acetaminophen/NSAID, or unable to speak or read English were excluded. Participants gave informed consent and were enrolled by a member of the study team at their preoperative appointments or in the pre-operative area the morning of their scheduled surgery. Preoperatively, baseline demographic and medical history information were obtained and participants completed validated surveys including the 9 question Central Sensitization Index (CSI-9), 13 item Pain Catastrophizing Scale (PCS), and Likert pain score (scale 0-10). Participants were randomized to either receive a standard prescription of ten 5 mg tablets oxycodone provided preoperatively (standard) or opioid prescription of ten 5 mg tablets provided only upon patient request postoperatively (restricted). The randomization allocation sequence was generated by the statistician using permuted blocks of random size 2, 4, and 6 with a 1:1 allocation ratio to standard or restricted regimen. Randomization was performed by the study team surgeon using the REDCap randomization module on the day of surgery. After MUS, subjects completed a daily diary for 1 week, i.e., postoperative day (POD) 0 through 7, to determine average daily pain score, opioid use and amount utilized, other forms of pain management, satisfaction with pain control, perception of the amount of opioid prescribed, and need to return to care for pain management. Diaries were collected electronically via REDCap or on a paper log if no internet access. The online Prescription Drug Monitoring Program (PDMP) was queried for all patients to determine if prescriptions for opioids were filled during the postoperative period. The primary outcome for this non-inferiority study was postoperative day 1 pain based on a Likert scale ranging from 0-10, where higher scores indicate worse pain. Secondary outcomes included whether subject filled an opioid prescription, opioid use (yes/no), satisfaction with pain control (on a scale of 1= “much worse” to 5= “much better” than expected), and how subjects felt about the amount of opioid prescribed (on a scale of 1=”prescribed far more” to 3=”prescribed the right amount” to 5=”prescribed far less” opioid than needed). Opioid use was determined using the daily POD0-POD7 diaries and defined as using at least 1 oxycodone 5mg tablet. An average score per participant was calculated for the 5-point Likert scale questions regarding satisfaction and amount of opioid prescribed, which were both assessed on the daily diaries. Analyses were performed using SAS Software, version 9.4.