CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Bupivicaine, Hydromorphone +1 moredrug
Likely dose
Bupivicaine, Hydromorphone 0.015mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00644111
NCT00644111N/ACompleted

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

University Health Network, Toronto·interventional·Posted Mar 26, 2008·Updated Feb 13, 2013

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 26, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.3 years ago

Interventions

Bupivicaine, Hydromorphonedrug

0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2

Saline Placebodrug

Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1