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

February 11, 2013 updated by: University Health Network, Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital, University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled to undergo minimally invasive lumbar decompression and fusion at the Toronto Western Hospital
  • both genders
  • ASA I to III
  • BMI less than 35

Exclusion Criteria:

  • refuses treatment randomization
  • inability to give informed consent
  • language barrier
  • local anesthetic allergy
  • allergy to shellfish or eggs
  • bleeding diathesis
  • sickle cell disease or trait
  • pregnancy
  • drug addiction
  • psychiatric history
  • severe intercurrent illness (ASA IV or V)
  • patients requiring anesthesia of other surgical sites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Control group receiving saline placebo through an epidural catheter
Drug: Saline Placebo
Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
Active Comparator: 2
Experimental group receiving active medication through the epidural catheter
Drug: Bupivicaine, Hydromorphone
0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in opioid consumption in the first 48 hours post-operatively
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in VRS pain scores
Time Frame: Duration of Admission
Duration of Admission
Reduction in total opioid consumption
Time Frame: Duration of Admission
Duration of Admission
Reduction in opioid related side effects
Time Frame: Duration of Admission
Duration of Admission
Reduction in time to discharge
Time Frame: Duration of Admission
Duration of Admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Stephen Choi, MD, Resident Physician, Deparment of Anesthesia, University of Toronto
  • Principal Investigator: Richard T Brull, MD, Department of Anesthesia, University Health Network, Toronto Western Hospital
  • Principal Investigator: Yoga R Rampersaud, MD, Deparment of Surgery, Division of Orthopedics, University Health Network, Toronto Western Hospital
  • Study Director: Vincent WS Chan, MD, Department of Anesthesia, University Health Network, Toronto Western Hospital
  • Study Director: Paul S Tumber, MD, Department of Anesthesia, University Health Network, Toronto Western Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN 07-0736-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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