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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Bupivicaine, Hydromorphone; Drug: Saline Placebo

• Registration Number: NCT00644111
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Bupivicaine, Hydromorphone	Experimental group receiving active medication through the epidural catheter
1	Saline Placebo	Control group receiving saline placebo through an epidural catheter

Primary Outcome Measures

Name	Time	Method
Reduction in opioid consumption in the first 48 hours post-operatively	48 hours

Secondary Outcome Measures

Name	Time	Method
Reduction in total opioid consumption	Duration of Admission
Reduction in VRS pain scores	Duration of Admission
Reduction in time to discharge	Duration of Admission
Reduction in opioid related side effects	Duration of Admission

Trial Locations

Locations (1)

Toronto Western Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada