At a glance
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Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
In Brief
A clinical study evaluating Bupivicaine, Hydromorphone and Saline Placebo for Low Back Pain. Completed, enrolled 32 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1