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

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ClinicalTrials.gov Identifier: NCT00644111
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.


Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Bupivicaine, Hydromorphone Drug: Saline Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Study Start Date : February 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Reduction in opioid consumption in the first 48 hours post-operatively [ Time Frame: 48 hours ]

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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00644111     History of Changes
Other Study ID Numbers: UHN 07-0736-A
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

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
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics