drugset / Trial / NCT03115151

Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery

NCT03115151

Phase 4 Terminated 46 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.

Timeline

Start
2017-05-08
Primary completion
2022-08-18
Completion
2023-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.0625 % Other
Subject Fentanyl Other / unclassified 2 ug/ml Other
Comparator Hydromorphone Other / unclassified 25 mg Intravenous

Indications

No indication recorded.