| March 20, 2008 |
| August 7, 2009 |
| February 2008 |
| March 2010 (final data collection date for primary outcome measure) |
| Reduction in opioid consumption in the first 48 hours post-operatively [ Time Frame: 48 hours ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00644111 on ClinicalTrials.gov Archive Site |
- Reduction in VRS pain scores [ Time Frame: Duration of Admission ] [ Designated as safety issue: No ]
- Reduction in total opioid consumption [ Time Frame: Duration of Admission ] [ Designated as safety issue: No ]
- Reduction in opioid related side effects [ Time Frame: Duration of Admission ] [ Designated as safety issue: No ]
- Reduction in time to discharge [ Time Frame: Duration of Admission ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion |
| Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion |
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. |
| |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment |
| Low Back Pain |
- Drug: Bupivicaine, Hydromorphone
- Drug: Saline Placebo
|
- Placebo Comparator: Control group receiving saline placebo through an epidural catheter
- Active Comparator: Experimental group receiving active medication through the epidural catheter
|
- Kundra P, Gurnani A, Bhattacharya A. Preemptive epidural morphine for postoperative pain relief after lumbar laminectomy. Anesth Analg. 1997 Jul;85(1):135-8.
- Schenk MR, Putzier M, Kügler B, Tohtz S, Voigt K, Schink T, Kox WJ, Spies C, Volk T. Postoperative analgesia after major spine surgery: patient-controlled epidural analgesia versus patient-controlled intravenous analgesia. Anesth Analg. 2006 Nov;103(5):1311-7.
- Turner A, Lee J, Mitchell R, Berman J, Edge G, Fennelly M. The efficacy of surgically placed epidural catheters for analgesia after posterior spinal surgery. Anaesthesia. 2000 Apr;55(4):370-3.
- Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82.
- Gottschalk A, Freitag M, Tank S, Burmeister MA, Kreil S, Kothe R, Hansen-Algenstedt N, Weisner L, Staude HJ, Standl T. Quality of postoperative pain using an intraoperatively placed epidural catheter after major lumbar spinal surgery. Anesthesiology. 2004 Jul;101(1):175-80.
- Blumenthal S, Min K, Nadig M, Borgeat A. Double epidural catheter with ropivacaine versus intravenous morphine: a comparison for postoperative analgesia after scoliosis correction surgery. Anesthesiology. 2005 Jan;102(1):175-80.
- Ray CD, Bagley R. Indwelling epidural morphine for control of post-lumbar spinal surgery pain. Neurosurgery. 1983 Oct;13(4):388-93.
- Cohen BE, Hartman MB, Wade JT, Miller JS, Gilbert R, Chapman TM. Postoperative pain control after lumbar spine fusion. Patient-controlled analgesia versus continuous epidural analgesia. Spine. 1997 Aug 15;22(16):1892-6; discussion 1896-7.
- Fisher CG, Belanger L, Gofton EG, Umedaly HS, Noonan VK, Abramson C, Wing PC, Brown J, Dvorak MF. Prospective randomized clinical trial comparing patient-controlled intravenous analgesia with patient-controlled epidural analgesia after lumbar spinal fusion. Spine. 2003 Apr 15;28(8):739-43.
- Park Y, Ha JW. Comparison of one-level posterior lumbar interbody fusion performed with a minimally invasive approach or a traditional open approach. Spine. 2007 Mar 1;32(5):537-43.
- Podichetty VK, Spears J, Isaacs RE, Booher J, Biscup RS. Complications associated with minimally invasive decompression for lumbar spinal stenosis. J Spinal Disord Tech. 2006 May;19(3):161-6.
- Sandhu NS, Sidhu DS, Capan LM. The cost comparison of infraclavicular brachial plexus block by nerve stimulator and ultrasound guidance. Anesth Analg. 2004 Jan;98(1):267-8. No abstract available.
- Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates of risk. Anesth Analg. 2007 Apr;104(4):965-74. Review.
- Foley KM. The treatment of cancer pain. N Engl J Med. 1985 Jul 11;313(2):84-95. Review.
- Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. No abstract available.
|
| |
| Recruiting |
| 32 |
| March 2010 |
| March 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 80 Years |
| No |
|
|
| Canada |
| |
| NCT00644111 |
| Dr. Richard T. Brull, Dr. Stephen Choi, Department of Anesthesia, Toronto Western Hospital, University Health Network |
| UHN 07-0736-A |
| University Health Network, Toronto |
|
| 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 |
|
|
| University Health Network, Toronto |
| July 2009 |
