Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Back Pain
Intervention: Bupivicaine, Hydromorphone (Drug); Saline Placebo (Drug)
Sponsored by: University Health Network, Toronto
Official(s) and/or principal investigator(s):
Stephen Choi, MD, Principal Investigator, Affiliation: Resident Physician, Deparment of Anesthesia, University of Toronto
Richard T Brull, MD, Principal Investigator, Affiliation: Department of Anesthesia, University Health Network, Toronto Western Hospital
Yoga R Rampersaud, MD, Principal Investigator, Affiliation: Deparment of Surgery, Division of Orthopedics, University Health Network, Toronto Western Hospital
Vincent WS Chan, MD, Study Director, Affiliation: Department of Anesthesia, University Health Network, Toronto Western Hospital
Paul S Tumber, MD, Study Director, Affiliation: Department of Anesthesia, University Health Network, Toronto Western Hospital
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.
Official title: Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Reduction in opioid consumption in the first 48 hours post-operatively
Reduction in VRS pain scores
Reduction in total opioid consumption
Reduction in opioid related side effects
Reduction in time to discharge
Minimum age: 18 Years.
Maximum age: 80 Years.
- 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
- 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
- drug addiction
- psychiatric history
- severe intercurrent illness (ASA IV or V)
- patients requiring anesthesia of other surgical sites
Locations and Contacts
Toronto Western Hospital, University Health Network, Toronto, Ontario M5T 2S8, Canada
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Starting date: February 2008
Last updated: February 11, 2013