Restrictive Opioid Prescribing after Surgery for Prolapse and Incontinence: A Randomized, Noninferiority Trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery, with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk of opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown.

OBJECTIVE: To determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in patient satisfaction with pain control, after minor and major surgeries for prolapse and incontinence.

STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (e.g., colporrhaphy or mid-urethral sling) and major (e.g., vaginal or minimally-invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the Standard Opioid Prescription Protocol (wherein patients routinely received an opioid prescription upon discharge [i.e., 3-10 tablets of oxycodone 5 mg]) or to the Restrictive Protocol (no opioid prescription, unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6 week postoperative visit. We hypothesized that patient satisfaction with the Restrictive Protocol would be noninferior to those with the Standard Protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare utilization were secondary outcomes assessed for superiority.

RESULTS: A total of 133 patients were randomized, and 127 (64 in the Standard arm and 63 in the Restrictive arm) completed the primary outcome and were included in the analysis. There were no statistically significant differences between study groups, including with surgery type. Major urogynecologic surgery was performed in 73.6% of the study population and minor surgery in 26.4%. Same-day discharge occurred in 87.6% of all subjects. Patient satisfaction was 92.2% in the Standard Protocol arm and 92.1% in the Restrictive Protocol arm (difference -0.1%; p=.004) which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of patients in the Standard Protocol arm and 70.8% in the Restrictive Protocol arm (p=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between study groups (9.4% Standard arm vs. 6.7% Restrictive arm, p= .661). No difference was seen in the rate of telephone calls and urgent visits for pain control between study arms.

CONCLUSION: In women undergoing minor and major surgery for prolapse and incontinence, patient satisfaction rates are noninferior after restrictive opioid prescribing compared to routine opioid prescribing.