NCT04710277

Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study is a randomized controlled trial investigating a multimodal postoperative pain management protocol which will include use of ice therapy and scheduled opioid-sparing medications for pain control after minimally invasive gynecologic surgery.

Detailed description

The study is a randomized controlled trial investigating a multimodal postoperative pain management protocol which will include use of ice therapy and scheduled opioid-sparing medications for pain control after minimally invasive gynecologic surgery. The study will include women \>/= 18yo who speak English and are admitted for observation after a qualifying laparoscopic or robotic gynecologic procedure. The investigators will identify potential participants from the operating schedule, screen for any exclusion criteria, and approach those eligible for inclusion on the day of surgery. All participants will receive a pain regimen with medications commonly used to manage post-surgical pain including nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and prescription opioids. Participants randomized to the intervention arm will receive prolonged scheduled NSAID and acetaminophen (96 hours instead of 24 hours) and will receive 24 hours of intermittent ice-therapy (20 minutes every 2-3 hours) on their abdominal incisions beginning within 1-2 hours after surgery. On post-operative day or day 1, a study investigator will administer a study questionnaire to all participants which will include a pain score, satisfaction score, and quality of recovery validated survey (the QoR-40). After discharge, participants will complete short web-based survey questionnaires on day 2 and 3. On day 4 a final and more comprehensive web-based survey will be sent to all participants which will include the 24-hour assessment in addition to the QoR-40 questionnaire, a final satisfaction questionnaire, and pill counts of left-over discharge medications. The day 4 survey completes the participants active part in the study. On or after day 30 a chart review will be performed to assess for post-operative complications, emergency room visits, telephone calls, unexpected office visits, and refill requests. An Ohio Rx Reporting System (OARRS) report will further screen for any additional narcotic prescriptions in the 30 day postoperative period. This will mark completion of participation in study. The completion of the study questionnaires is anticipated to take about 1.5 to 2 hours in total time throughout the study. There are no additional clinic visits or costs associated with participation in this study.

Conditions

• Postoperative Pain
• Narcotic Use
• Cryotherapy Effect

Interventions

Type	Name	Description
OTHER	Opioid-sparing multimodal pain management	Ice pack applied to abdominal incisions for 20 minutes every 2 to 3 hours for 24 hours after surgery and scheduled acetaminophen and NSAID for 96 hours after surgery. Narcotic pain medication for severe breakthrough pain.
OTHER	Usual care	Scheduled acetaminophen and NSAID for 24 hours after surgery. Narcotic pain medication for severe breakthrough pain.

Timeline

• Start date: 2021-04-19
• Primary completion: 2022-09-20
• Completion: 2022-10-20
• First posted: 2021-01-14
• Last updated: 2023-05-12

Locations

1 site across 1 country: United States