drugset / Trial / NCT05413902

Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery

NCT05413902

Phase 4 Completed 100 enrolled University of Puerto Rico
RandomizedParallel-groupSingle-blindSupportive care

Summary

This study consisted of a randomized controlled trial designed to evaluate a Multimodal Analgesia (MMA) Protocol on patients undergoing Posterior Spinal Fusion. The purpose is to describe the narcotic requirements and usage during the perioperative period of posterior spinal fusion and instrumentation surgery with the implementation of multimodal anesthesia protocol. The study will consist of two parallel arms, with Group 1 receiving our MMA protocol and Group 2 receiving a traditional opioid-based regime. The primary outcome of this study will be the reported Visual Analog Scale (VAS) for pain at 12, 24, and 48 hours after surgery. We considered that our findings could contribute to the fight against the opioid crisis proving alternatives to opioids as feasible alternatives for pain management even in significant surgery, as is posterior spinal fusion with instrumentation.

Timeline

Start
2021-04-05
Primary completion
2022-01-28
Completion
2022-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg Oral
Subject Bupivacaine Other / unclassified 30 ml Other
Subject Epinephrine Other / unclassified 1 ml Other
Subject Gabapentin Small molecule 300 mg Oral
Subject Ketorolac Tromethamine Small molecule 30 mg Intravenous
Subject Methylprednisolone Other / unclassified 125 mg
Comparator Morphine Other / unclassified 4 mg Intravenous
Subject Orphenadrine Small molecule 100 mg Oral
Subject Xylocaine Injectable Solution Unknown 0.5 % Intramuscular

Indications

No indication recorded.