Clinical trial NCT00644111: Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Official title: Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Minimally Invasive Decompression and Fusion
Postoperative analgesia
Epidural
Lumbar
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction in opioid consumption in the first 48 hours post-operatively
timeFrame: 48 hours
Secondary outcomes:
measure: Reduction in VRS pain scores
timeFrame: Duration of Admission
measure: Reduction in total opioid consumption
timeFrame: Duration of Admission
measure: Reduction in opioid related side effects
timeFrame: Duration of Admission
measure: Reduction in time to discharge
timeFrame: Duration of Admission
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
affiliation: Resident Physician, Deparment of Anesthesia, University of Toronto
name: Stephen Choi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesia, University Health Network, Toronto Western Hospital
name: Richard T Brull, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deparment of Surgery, Division of Orthopedics, University Health Network, Toronto Western Hospital
name: Yoga R Rampersaud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesia, University Health Network, Toronto Western Hospital
name: Vincent WS Chan, MD
role: STUDY_DIRECTOR
affiliation: Department of Anesthesia, University Health Network, Toronto Western Hospital
name: Paul S Tumber, MD
role: STUDY_DIRECTOR
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