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

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00644111

Purpose

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	Intervention
Low Back Pain	Drug: Bupivicaine, Hydromorphone Drug: Saline Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment
Official Title:	Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Hydromorphone hydrochloride Hydromorphone

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Reduction in opioid consumption in the first 48 hours post-operatively [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	32
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Control group receiving saline placebo through an epidural catheter	Drug: Saline Placebo Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
2: Active Comparator Experimental group receiving active medication through the epidural catheter	Drug: Bupivicaine, Hydromorphone 0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644111

Contacts

Contact: Stephen Choi, MD		schoi2005@gmail.com
Contact: Richard T Brull, MD	416-603-5118	richard.brull@uhn.on.ca

Locations

Canada, Ontario
Toronto Western Hospital, University Health Network	Recruiting
Toronto, Ontario, Canada, M5T 2S8

Sponsors and Collaborators

University Health Network, Toronto

Investigators

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

More Information

Publications:

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.

Responsible Party:	Department of Anesthesia, Toronto Western Hospital, University Health Network ( Dr. Richard T. Brull, Dr. Stephen Choi )
Study ID Numbers:	UHN 07-0736-A
Study First Received:	March 20, 2008
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00644111 History of Changes
Health Authority:	Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by University Health Network, Toronto:

Minimally Invasive Decompression and Fusion
Postoperative analgesia
Epidural
Lumbar

Study placed in the following topic categories:

Hydromorphone
Low Back Pain
Anesthetics
Central Nervous System Depressants
Narcotics
Pain
Back Pain

Anesthetics, Local
Signs and Symptoms
Neurologic Manifestations
Bupivacaine
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Hydromorphone
Nervous System Diseases
Physiological Effects of Drugs
Low Back Pain
Anesthetics
Central Nervous System Depressants
Narcotics
Pain
Back Pain
Anesthetics, Local

Pharmacologic Actions
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Bupivacaine
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 10, 2009