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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00644111
First received: March 20, 2008
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Low Back Pain
 Drug: Bupivicaine, Hydromorphone
Drug: Saline Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Reduction in opioid consumption in the first 48 hours post-operatively [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in VRS pain scores [ Time Frame: Duration of Admission ] [ Designated as safety issue: No ]
  • Reduction in total opioid consumption [ Time Frame: Duration of Admission ] [ Designated as safety issue: No ]
  • Reduction in opioid related side effects [ Time Frame: Duration of Admission ] [ Designated as safety issue: No ]
  • Reduction in time to discharge [ Time Frame: Duration of Admission ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644111

Locations
Canada, Ontario
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00644111     History of Changes
Other Study ID Numbers: UHN 07-0736-A
Study First Received: March 20, 2008
Last Updated: February 11, 2013
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by University Health Network, Toronto:
Minimally Invasive Decompression and Fusion
Postoperative analgesia
Epidural
Lumbar

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Hydromorphone
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013