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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bupivicaine, Hydromorphone
Saline Placebo
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Minimally Invasive Decompression and Fusion, Postoperative analgesia, Epidural, Lumbar

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western Hospital, University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Control group receiving saline placebo through an epidural catheter

Experimental group receiving active medication through the epidural catheter

Outcomes

Primary Outcome Measures

Reduction in opioid consumption in the first 48 hours post-operatively

Secondary Outcome Measures

Reduction in VRS pain scores
Reduction in total opioid consumption
Reduction in opioid related side effects
Reduction in time to discharge

Full Information

First Posted
March 20, 2008
Last Updated
February 11, 2013
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00644111
Brief Title
Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Official Title
Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Minimally Invasive Decompression and Fusion, Postoperative analgesia, Epidural, Lumbar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Control group receiving saline placebo through an epidural catheter
Arm Title
2
Arm Type
Active Comparator
Arm Description
Experimental group receiving active medication through the epidural catheter
Intervention Type
Drug
Intervention Name(s)
Bupivicaine, Hydromorphone
Intervention Description
0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
Intervention Type
Drug
Intervention Name(s)
Saline Placebo
Intervention Description
Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
Primary Outcome Measure Information:
Title
Reduction in opioid consumption in the first 48 hours post-operatively
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Reduction in VRS pain scores
Time Frame
Duration of Admission
Title
Reduction in total opioid consumption
Time Frame
Duration of Admission
Title
Reduction in opioid related side effects
Time Frame
Duration of Admission
Title
Reduction in time to discharge
Time Frame
Duration of Admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Choi, MD
Organizational Affiliation
Resident Physician, Deparment of Anesthesia, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard T Brull, MD
Organizational Affiliation
Department of Anesthesia, University Health Network, Toronto Western Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoga R Rampersaud, MD
Organizational Affiliation
Deparment of Surgery, Division of Orthopedics, University Health Network, Toronto Western Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent WS Chan, MD
Organizational Affiliation
Department of Anesthesia, University Health Network, Toronto Western Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul S Tumber, MD
Organizational Affiliation
Department of Anesthesia, University Health Network, Toronto Western Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Citations:
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9212136
Citation
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Citation
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Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

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