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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 26, 2008
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Health Network, Toronto

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: 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

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: February 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
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
Active Comparator: 2
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Information from the National Library of Medicine

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
Sponsors and Collaborators
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
  More Information

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 (Phila Pa 1976). 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 (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.
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00644111     History of Changes
Other Study ID Numbers: UHN 07-0736-A
First Submitted: March 20, 2008
First Posted: March 26, 2008
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by University Health Network, Toronto:
Minimally Invasive Decompression and Fusion
Postoperative analgesia

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid

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