Trial of a Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery

Objectives: To assess the impact of a novel multimodal pain management protocol as compared to standard pain management following minimally invasive (laparoscopic or robotic) major gynecologic surgery.

Methods: This is a randomized controlled trial conducted at a tertiary care center. Inclusion criteria include being English-speaking, age 18 or older, having reliable internet access, and undergoing a qualifying surgery (pelvic floor procedures, e.g., sacrocolpopexy; or hysterectomy with or without concomitant vaginal surgery or minor procedures). Exclusion criteria include pregnancy, chronic pelvic pain, history of chronic opioid use, current daily opioid use, contraindication to study medications, study medication allergy or intolerance, and cognitive disability. Intraoperative exclusion criteria were conversion to vaginal procedure or laparotomy and major intraoperative complications. We assessed postoperative pain, patient satisfaction, quality of recovery, and medication use from day of surgery to postoperative day (POD) 4. Randomization to the intervention group (novel multimodal pain control protocol) and the control group (standard protocol) occurred immediately postoperatively and were initiated as soon as clinically appropriate. The intervention protocol included scheduled acetaminophen and NSAID for 96 hours and topical ice therapy for 24 hours after surgery. The standard protocol included scheduled acetaminophen and NSAID for the first 24 hours after surgery without scheduled ice therapy. Participant follow up consisted of a web-based survey on POD 1 to 4. Additional outcomes were obtained on POD 30 by chart review.

The primary outcome is the POD 1 pain score by an 11-point numerical rating (NRS-11). Secondary outcomes include pain scores leaving the PACU, and POD 2 to 4 (NRS-11); quality of recovery questionnaire (the QoR-40) on POD 1 and POD 4; patient satisfaction (NRS-11) with pain control and ice therapy (for applicable patients) on POD 1 and POD 4; opioid use; 30-day outcomes (postoperative complications, unexpected office phone calls or visits, emergency room visits, readmissions, and medication refill requests); and adverse events.

Results: 54 patients were randomized, 28 to intervention and 26 to the control group. Primary outcome data revealed no difference between groups in POD 1 pain (median 4 [2-6] vs. 4 [2-4], p=0.71). The intervention group used less prescribed opioid tablets than the control group (0 [0-6] vs. 2 [0-5]). There was no difference in total oral morphine equivalents in the first 24 hours and pain scores on POD 2 to 4. There was no difference in quality of recovery, patient satisfaction, and 30-day outcomes. 78.3% found ice therapy helpful. 82.6% would use it again. One adverse event occurred with ice pack use (skin irritation) in the control group.

Conclusions: Ice packs after minimally invasive gynecologic surgery are overall helpful for pain control. Although there was no difference in postoperative pain scores, they are well tolerated and may decrease the need for use of opioids.