Low Back Pain
Conditions
Keywords
Minimally Invasive Decompression and Fusion, Postoperative analgesia, Epidural, Lumbar
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.
Interventions
DRUGBupivicaine, Hydromorphone
0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
DRUGSaline Placebo
Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in opioid consumption in the first 48 hours post-operatively | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in time to discharge | Duration of Admission |
| 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 |
Countries
Canada
Outcome results
None listed