NCT01986946

Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study 2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia. Hypothesis: The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.

Conditions

• Lumbar Spine Fusion
• Pain
• Back Pain

Interventions

Type	Name	Description
OTHER	Epidural Catheter - Dilaudid	Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
DRUG	Dilaudid	Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-11-19
• Last updated: 2017-02-23
• Results posted: 2016-11-11

Locations

1 site across 1 country: United States