drugset / Trial / NCT04429022

Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

NCT04429022

Phase 3 Completed 68 enrolled State University of New York at Buffalo
Non-randomizedSequentialOpen-labelTreatment

Summary

Hysterectomy is the most common major gynecologic surgery performed in the US and is performed for a variety of indications including malignancy, pelvic mass, endometriosis, leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control post-operatively is opioid-based however in light of the opioid epidemic, a transition to non-opioid pain medication regimens is desired by both physicians and patients alike. The goal of this study is to develop a multimodal non-opioid pain medication regimen that minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy. Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm from November, 2020 to November, 2022. Included in our treatment protocol is paracervical block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain scores will additionally be measured.

Timeline

Start
2020-11-24
Primary completion
2022-05-31
Completion
2022-05-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg Oral
Subject Celecoxib Other / unclassified 200 mg Oral
Subject Gabapentin Small molecule 300 mg Oral
Subject Ketorolac Other / unclassified 30 mg Intravenous
Subject Oxycodone Other / unclassified 5 mg
Background Hydromorphone Other / unclassified 1 mg Intravenous

Indications

No indication recorded.