Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

Phase 3

Terminated

Brief 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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Epidural Catheter	Epidural Catheter - Dilaudid	The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.
Intravenous opioids	Dilaudid	This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.

Primary Outcome Measures

Name	Time	Method
Post-operative Pain as Assessed by Visual Analogue Scale (VAS)	Postoperative day 1	The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Readmitted to Hospital Within 30 Days of Surgery	Post-operative Day 30
Wound Infection Rates	during hospitalization (approximately 3-8 days)
Patient Satisfaction With Perioperative Analgesia	6-Week Follow up Visit	Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Patient Satisfaction With Overall Care	6-Week Follow up Visit	Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Number of Participants With Events of Special Interest	Post-operative Day 30	Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.
Length of Hospital Stay	during hospitalization (approximately 3-8 days)
Number of Participants Experiencing Delirium	Post-operative Day 3
Number of Participants With Adverse Events Related to the Study	6-week Follow up Visit	Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
Total Post-operative Opioid Consumption	during hospitalization (approximately 3-8 days)