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Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
This study is currently recruiting participants.
Study NCT00644111   Information provided by University Health Network, Toronto
First Received: March 20, 2008   Last Updated: August 7, 2009   History of Changes

March 20, 2008
August 7, 2009
February 2008
March 2010   (final data collection date for primary outcome measure)
Reduction in opioid consumption in the first 48 hours post-operatively [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00644111 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

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.

 
 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment
Low Back Pain
  • Drug: Bupivicaine, Hydromorphone
  • Drug: Saline Placebo
  • Placebo Comparator: Control group receiving saline placebo through an epidural catheter
  • Active Comparator: Experimental group receiving active medication through the epidural catheter

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
32
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Stephen Choi, MD schoi2005@gmail.com
Contact: Richard T Brull, MD 416-603-5118 richard.brull@uhn.on.ca
Canada
 
NCT00644111
Dr. Richard T. Brull, Dr. Stephen Choi, Department of Anesthesia, Toronto Western Hospital, University Health Network
UHN 07-0736-A
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
University Health Network, Toronto
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP