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Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

NCT00644111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-02-13

No results posted yet for this study

Summary

Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to reduce post-operative pain, opioid consumption and related side effects, and length of hospital stay. Current research demonstrates a modest improvement in these areas beginning on the third post-operative day. MIS fusion, however, incurs significant cost as the average time of the procedure is approximately one third greater (from 148 minutes to 191 on average). Epidural analgesia has clearly demonstrated benefits for conventional open laminectomy. In order to fully maximize the benefits of an MIS technique, early post-operative analgesia/pain must be improved. The aim of this study is to combine two techniques to ultimately improve patient outcomes and satisfaction. This will be a randomized trial involving 32 patients undergoing MIS decompression and fusion with half the study group receiving active epidural and IV-PCA and the other half receiving epidural placebo and IV-PCA.

The hypothesis is that epidural analgesia will reduce post-operative opioid consumption, improve pain scores, and decrease time to ambulation as well as discharge from hospital after MIS decompression and fusion.

Conditions

  • Low Back Pain

Interventions

DRUG

Bupivicaine, Hydromorphone

0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2

DRUG

Saline Placebo

Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Stephen Choi, MD · Resident Physician, Deparment of Anesthesia, University of Toronto

  • Richard T Brull, MD · Department of Anesthesia, University Health Network, Toronto Western Hospital

  • Yoga R Rampersaud, MD · Deparment of Surgery, Division of Orthopedics, University Health Network, Toronto Western Hospital

  • Vincent WS Chan, MD · Department of Anesthesia, University Health Network, Toronto Western Hospital

  • Paul S Tumber, MD · Department of Anesthesia, University Health Network, Toronto Western Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Canada

Study Locations

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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 NCT00644111 on ClinicalTrials.gov