Liberal vs. restricted opioid prescribing following midurethral sling dataset.

Postoperative opioid prescribing has historically lacked information critical to balancing the pain control needs of the individual patient with our professional responsibility to judiciously prescribe these high-risk medications. This data evaluates 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. This study was registered on clinicaltrials.gov (NCT04277975). Women undergoing isolated MUS by a Female Pelvic Medicine and Reconstructive Surgery physician at a Penn State Health hospital from June 1, 2020 to November 22, 2021 were offered enrollment into this prospective, randomized, open-label, non-inferiority clinical trial. Participants gave informed consent and were enrolled by a member of the study team. Allocation was concealed to patient and study personnel until randomization on the day of surgery. Preoperatively, all participants completed baseline demographic and pain surveys including CSI-9, 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 provided only upon patient request postoperatively (restricted). Randomization was performed by the study team surgeon using the REDCap randomization module on the day of surgery. Following MUS, subjects completed a daily diary for 1 week, i.e., postoperative day (POD) 0 through 7. Within the dairy, subjects provided the following information: average daily pain score, opioid use and amount of opioid utilized, other forms of pain management, satisfaction with pain control, perception of the amount of opioid prescribed, and need for pain management hospital/clinic visits. 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 was average postoperative day 1 pain score and an a priori determined margin of non-inferiority was set at 2 points. Secondary outcomes included whether subject filled an opioid prescription (indicated by the online PDMP), 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). 82 participants underwent isolated MUS placement and met inclusion criteria; 40 were randomized to the standard arm and 42 to the restricted group. Within this manuscript, we detail the data obtained from this randomized clinical trial and the methods utilized.

A randomized trial of standard vs restricted opioid prescribing following midurethral sling.

BACKGROUND: Postoperative opioid prescribing has historically lacked information crucial to balancing the pain control needs of the individual patient with our professional responsibility to judiciously prescribe these high-risk medications. OBJECTIVE: This study aimed to evaluate pain control, satisfaction with pain control, and opioid use among patients undergoing isolated midurethral sling randomized to 1 of 2 different opioid-prescribing regimens. STUDY DESIGN: Patients who underwent isolated midurethral sling placement from June 1, 2020, to November 22, 2021, were offered enrollment into this prospective, randomized, open-label, noninferiority clinical trial. Participants were randomized to receive either a standard prescription of ten 5-mg oxycodone tablets provided preoperatively (standard) or an opioid prescription provided only during patient request postoperatively (restricted). Preoperatively, all participants completed baseline demographic and pain surveys, including the 9-Question Central Sensitization Index, Pain Catastrophizing Scale, and Likert pain score (scale 0-10). The participants completed daily surveys for 1 week after surgery to determine the average daily pain score, number of opioids used, other forms of pain management, satisfaction with pain control, perception of the number of opioids prescribed, and need to return to care for pain management. The online Prescription Drug Monitoring Program was used to determine opioid filling in the postoperative period. The primary outcome was average postoperative day 1 pain score, and an a priori determined margin of noninferiority was set at 2 points. RESULTS: Overall, 82 patients underwent isolated midurethral sling placement and met the inclusion criteria: 40 were randomized to the standard arm, and 42 were randomized to the restricted group. Concerning the primary outcome of average postoperative day 1 pain score, the restricted arm (mean pain score, 3.9±2.4) was noninferior to the standard arm (mean pain score, 3.7±2.7; difference in means, 0.23; 95% confidence interval, -∞ to 1.34). Of note, 23 participants (57.5%) in the standard arm vs 8 participants (19.0%) in the restricted arm filled an opioid prescription (P<.001). Moreover, 18 of 82 participants (22.0%) used opioids during the 7-day postoperative period, with 10 (25.0%) in the standard arm and 8 (19.0%) in the restricted arm using opioids (P=.52). Of participants using opioids, the average number of tablets used was 3.4±2.3, and only 3 participants used ≥5 tablets. On a scale of 1="prescribed far more opioids than needed" to 5="prescribed far less opioids than needed," the means were 1.9±1.0 in the standard arm and 2.7±1.0 in the restricted arm (P<.001). CONCLUSION: Restricted opioid prescription was noninferior to standard opioid prescription in the setting of pain control and satisfaction with pain control after isolated midurethral placement. Participants in the restricted arm filled fewer opioid prescriptions than participants in the standard arm. 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.

Characteristics of patients undergoing hysterectomy for failed endometrial ablation.

BACKGROUND AND OBJECTIVES: Endometrial ablation is a minimally invasive procedure for menorrhagia. High success rates are documented with >90% of patients experiencing satisfaction. However, adequate relief after endometrial ablation is not obtained in a cohort of patients. The purpose of this study is to identify the characteristics of patients for whom endometrial ablation fails due to persistent symptoms, causing them to choose hysterectomy for definitive treatment. METHODS: We conducted a retrospective chart review of patients who underwent hysterectomy for persistent menorrhagia, pain, or both, who previously had endometrial ablation. We reviewed medical records including pathology reports from hysterectomy. We compared demographics to a group previously studied at our institution that were identified as satisfied 5 years after ablation. RESULTS: The number of patients in our study group was 51 (n = 51). Median age of patients was 39 (range 29-50) years. Average body mass index was 31 (range 19-47) kg/m(2). Average parity was 1.9. Sixty-nine percent underwent tubal ligation. The majority were nonsmokers (75%). Ninety-six percent were Caucasian. Compared with the previously studied satisfied group, the only statistically significant difference was age. Of 51 patients, 11 (22%) noted pelvic pain as their chief concern. Menorrhagia was the chief concern in 22 (43%). Eighteen patients (35%) complained of both. The most common diagnosis was endometriosis, which was identified in 35 patients (68%). Leiomyomata were present in 33 patients (64%). Adenomyosis was identified in 22 patients (43%). CONCLUSIONS: Patients who present for hysterectomy after endometrial ablation have a high rate of endometriosis, adenomyosis, and leiomyomata, with endometriosis being the most common finding.