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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

March 20, 2008
February 11, 2013
February 2008
July 2011   (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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • Drug: Bupivicaine, Hydromorphone
    0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
  • Drug: Saline Placebo
    Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
  • Placebo Comparator: 1
    Control group receiving saline placebo through an epidural catheter
    Intervention: Drug: Saline Placebo
  • Active Comparator: 2
    Experimental group receiving active medication through the epidural catheter
    Intervention: Drug: Bupivicaine, Hydromorphone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2011
July 2011   (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 information is only displayed when the study is recruiting subjects
Canada
 
NCT00644111
UHN 07-0736-A
Yes
University Health Network, Toronto
University Health Network, Toronto
Not Provided
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
February 2013

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