MedTrace Logo

Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

NCT01986946 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-02-23

Study results available
· View outcomes & findings →

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

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Erin L Manning, MD/PhD · Duke University Hospital Department of Anesthesiology

  • Carlos Bagley, MD · Duke University Hospital Department of Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01986946 on ClinicalTrials.gov