Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
NCT ID: NCT00644111
Last Updated: 2013-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2008-02-29
2011-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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1
Control group receiving saline placebo through an epidural catheter
Saline Placebo
Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
2
Experimental group receiving active medication through the epidural catheter
Bupivicaine, Hydromorphone
0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
Interventions
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Bupivicaine, Hydromorphone
0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
Saline Placebo
Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
Eligibility Criteria
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Inclusion Criteria
* both genders
* ASA I to III
* BMI less than 35
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Stephen Choi, MD
Role: PRINCIPAL_INVESTIGATOR
Resident Physician, Deparment of Anesthesia, University of Toronto
Richard T Brull, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia, University Health Network, Toronto Western Hospital
Yoga R Rampersaud, MD
Role: PRINCIPAL_INVESTIGATOR
Deparment of Surgery, Division of Orthopedics, University Health Network, Toronto Western Hospital
Vincent WS Chan, MD
Role: STUDY_DIRECTOR
Department of Anesthesia, University Health Network, Toronto Western Hospital
Paul S Tumber, MD
Role: STUDY_DIRECTOR
Department of Anesthesia, University Health Network, Toronto Western Hospital
Locations
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Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada
Countries
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References
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Kundra P, Gurnani A, Bhattacharya A. Preemptive epidural morphine for postoperative pain relief after lumbar laminectomy. Anesth Analg. 1997 Jul;85(1):135-8. doi: 10.1097/00000539-199707000-00024.
Schenk MR, Putzier M, Kugler 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. doi: 10.1213/01.ane/0000247966.49492.72.
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. doi: 10.1046/j.1365-2044.2000.01117.x.
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. doi: 10.1016/S0140-6736(02)08266-1.
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. doi: 10.1097/00000542-200407000-00027.
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. doi: 10.1097/00000542-200501000-00026.
Ray CD, Bagley R. Indwelling epidural morphine for control of post-lumbar spinal surgery pain. Neurosurgery. 1983 Oct;13(4):388-93. doi: 10.1227/00006123-198310000-00007.
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 (Phila Pa 1976). 1997 Aug 15;22(16):1892-6; discussion 1896-7. doi: 10.1097/00007632-199708150-00016.
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 (Phila Pa 1976). 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 (Phila Pa 1976). 2007 Mar 1;32(5):537-43. doi: 10.1097/01.brs.0000256473.49791.f4.
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. doi: 10.1097/01.bsd.0000188663.46391.73.
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):267-268. doi: 10.1213/01.ANE.0000077685.55641.7C. 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. doi: 10.1213/01.ane.0000258740.17193.ec.
Foley KM. The treatment of cancer pain. N Engl J Med. 1985 Jul 11;313(2):84-95. doi: 10.1056/NEJM198507113130205.
Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.
Choi S, Rampersaud YR, Chan VW, Persaud O, Koshkin A, Tumber P, Brull R. The addition of epidural local anesthetic to systemic multimodal analgesia following lumbar spinal fusion: a randomized controlled trial. Can J Anaesth. 2014 Apr;61(4):330-9. doi: 10.1007/s12630-014-0115-z. Epub 2014 Feb 12.
Other Identifiers
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UHN 07-0736-A
Identifier Type: -
Identifier Source: org_study_id
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