Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Peri-Incisional Drug Injection in Lumbar Spine Surgery

NCT03513445

Lumbar Disc Herniation Degenerative Disc Disease Spondylolisthesis

WITHDRAWN PHASE3

Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery

NCT00823576

Postoperative Pain

TERMINATED PHASE4

Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery

NCT01043211

Back Pain

WITHDRAWN NA

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

NCT03115151

Pain

TERMINATED PHASE4

A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery

NCT01117610

Postoperative Pain

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Spine Fusion Pain Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous opioids

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.

Group Type EXPERIMENTAL

Dilaudid

Intervention Type DRUG

Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).

Epidural Catheter

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.

Group Type EXPERIMENTAL

Epidural Catheter - Dilaudid

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Dilaudid

Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No