Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
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| ClinicalTrials.gov Identifier: NCT00644111 |
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Recruitment Status :
Completed
First Posted : March 26, 2008
Last Update Posted : February 13, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Low Back Pain | Drug: Bupivicaine, Hydromorphone Drug: Saline Placebo | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 32 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion |
| Study Start Date : | February 2008 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | July 2011 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 1
Control group receiving saline placebo through an epidural catheter
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Drug: Saline Placebo
Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1 |
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Active Comparator: 2
Experimental group receiving active medication through the epidural catheter
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Drug: Bupivicaine, Hydromorphone
0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2 |
- Reduction in opioid consumption in the first 48 hours post-operatively [ Time Frame: 48 hours ]
- Reduction in VRS pain scores [ Time Frame: Duration of Admission ]
- Reduction in total opioid consumption [ Time Frame: Duration of Admission ]
- Reduction in opioid related side effects [ Time Frame: Duration of Admission ]
- Reduction in time to discharge [ Time Frame: Duration of Admission ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644111
| Canada, Ontario | |
| Toronto Western Hospital, University Health Network | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Principal Investigator: | Stephen Choi, MD | Resident Physician, Deparment of Anesthesia, University of Toronto | |
| Principal Investigator: | Richard T Brull, MD | Department of Anesthesia, University Health Network, Toronto Western Hospital | |
| Principal Investigator: | Yoga R Rampersaud, MD | Deparment of Surgery, Division of Orthopedics, University Health Network, Toronto Western Hospital | |
| Study Director: | Vincent WS Chan, MD | Department of Anesthesia, University Health Network, Toronto Western Hospital | |
| Study Director: | Paul S Tumber, MD | Department of Anesthesia, University Health Network, Toronto Western Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00644111 |
| Other Study ID Numbers: |
UHN 07-0736-A |
| First Posted: | March 26, 2008 Key Record Dates |
| Last Update Posted: | February 13, 2013 |
| Last Verified: | February 2013 |
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Minimally Invasive Decompression and Fusion Postoperative analgesia Epidural Lumbar |
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Low Back Pain Back Pain Pain Neurologic Manifestations Hydromorphone Bupivacaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Narcotics Analgesics |