Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

Duke University

Status and phase: Terminated; Phase 3

Conditions: Lumbar Spine Fusion; Back Pain; Pain

Treatments: Drug: Dilaudid; Other: Epidural Catheter - Dilaudid

Study type: Interventional

Funder types: Other

Identifiers

NCT01986946

Pro00041252

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Intravenous opioids

Experimental group

Description:

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.

Treatment:

Drug: Dilaudid

Epidural Catheter

Experimental group

Description:

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.

Treatment:

Other: Epidural Catheter - Dilaudid