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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00644111

First received: March 20, 2008

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 20, 2008

Last Updated Date

February 11, 2013

Start Date ^ICMJE

February 2008

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00644111 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Drug: Bupivicaine, Hydromorphone
0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
Drug: Saline Placebo
Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1

Study Arm (s)

Placebo Comparator: 1
Control group receiving saline placebo through an epidural catheter

Intervention: Drug: Saline Placebo
Active Comparator: 2
Experimental group receiving active medication through the epidural catheter

Intervention: Drug: Bupivicaine, Hydromorphone

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00644111

Other Study ID Numbers ^ICMJE

UHN 07-0736-A

Has Data Monitoring Committee

Yes

Responsible Party

University Health Network, Toronto

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University Health Network, Toronto

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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