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

Study Overview
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Brief Summary
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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
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Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Bupivicaine, Hydromorphone
* Drug: Saline Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Control group receiving saline placebo through an epidural catheter | Drug: Saline Placebo<br>* Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1<br>|
| Active Comparator: 2<br>Experimental group receiving active medication through the epidural catheter | Drug: Bupivicaine, Hydromorphone<br>* 0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in opioid consumption in the first 48 hours post-operatively |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in VRS pain scores |  | Duration of Admission | 
| Reduction in total opioid consumption |  | Duration of Admission | 
| Reduction in opioid related side effects |  | Duration of Admission | 
| Reduction in time to discharge |  | Duration of Admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally Invasive Decompression and Fusion, Postoperative analgesia, Epidural, Lumbar