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

This study has been completed.
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: March 20, 2008
Last updated: February 11, 2013
Last verified: February 2013

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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • Reduction in VRS pain scores [ Time Frame: Duration of Admission ]
  • Reduction in total opioid consumption [ Time Frame: Duration of Admission ]
  • Reduction in opioid related side effects [ Time Frame: Duration of Admission ]
  • Reduction in time to discharge [ Time Frame: Duration of Admission ]

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00644111

Canada, Ontario
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Health Network, Toronto Identifier: NCT00644111     History of Changes
Other Study ID Numbers: UHN 07-0736-A
Study First Received: March 20, 2008
Last Updated: February 11, 2013

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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Analgesics processed this record on May 25, 2017