drugset / Trial / NCT04246697

Multimodal Pain Study in Free Flap Patients

NCT04246697

Phase 4 Completed 30 enrolled University of Kansas Medical Center
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will be a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period. Arm B will undergo scheduled Gabapentin, Ketorolac and Tylenol as well as the Anesthesiology team managing regional nerve blocks, with opioids available PRN in the peri-operative period. The amount of pain medication used by all patients will be recorded as well as pain scores documented on a pain scale (0-10 with 0 indicating no pain and 10 indicating worst pain ever) as well as ABC pain scale throughout the patients' hospital stay. Morphine equivalents for the opioids will be calculated for each arm while observing pain scores. Then, the investigators will compare these two groups to see if there is a difference in opioid pain medication used. The study team's hypothesis is that the use of Gabapentin, Ketorolac, and Tylenol in combination will significantly reduce (at least 30% of Mean Morphine Equivalents - MME) the use of opioid medication for patients undergoing head and neck free flap reconstruction with similar to improved pain scores.

Timeline

Start
2019-11-01
Primary completion
2021-06-01
Completion
2023-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.125 % Other
Subject Gabapentin Small molecule
Subject Ketorolac Tromethamine Small molecule 15 mg
Background Acetaminophen Small molecule 650 mg Intravenous
Background Morphine Other / unclassified 2 mg Intravenous
Background Oxycodone Other / unclassified 5 mg Oral

Indications