drugset / Trial / NCT05231460

Pain Management Study

NCT05231460

Phase 4 Enrolling by invitation 244 enrolled University of Arizona
RandomizedFactorialOpen-labelTreatment

Summary

This study aims to better understand the role that narcotic vs. non-narcotic multimodal pain management play in patients' pain following bariatric surgery (Laproscopic Surgery and Robotic Assisted Surgery). Participation in this study will last approximately 90 days following surgery. During that 90 day period, participants will be asked to report pain and nausea every 4 hours to a study coordinator or nurse while they are recovering in the hospital. Following discharge from the hospital patients will be asked to report pain, nausea, and any medical changes 7 days, 30 days, and 90 days from surgical date. The procedures and medications used in this study are FDA approved medical therapies and are part of Standard of Care for this population. This study aims to therapeutically investigate efficacy of the proposed pain management regimens. The procedures and individual medications are not the subject of research as they are considered routine well established and documented interventions for obesity and the treatment of post operative pain.

Timeline

Start
2022-02-18
Primary completion
2026-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 1000 mg
Comparator Gabapentin Small molecule 100 mg
Comparator Hydromorphone Other / unclassified 1 mg Intravenous
Comparator Ketorolac Tromethamine Small molecule 15 mg
Comparator Oxycodone Other / unclassified 5 mg Oral
Comparator Oxycodone Other / unclassified 10 mg Oral
Comparator Ropivacaine Other / unclassified 0.5 % Other
Comparator Ropivacaine Other / unclassified 15 ml Other

Indications