Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Analgesics, Opioid; Hydromorphone

Criteria

Inclusion Criteria:

• Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery

Exclusion Criteria:

• Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.

• Inability to follow directions or comprehend the English language.

• Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.

• Prisoners.

• Patient refusal to provide informed consent.

• Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).