Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion
NCT ID: NCT03035656
Last Updated: 2019-02-21
Study Results
Results pending
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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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
228 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-03-01
Study Completion Date
2022-03-01
Brief Summary
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The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2) Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if there are differences in pain management between MIS and open surgical procedures. The proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving MIS compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of Ropivaciane®.
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Detailed Description
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This double blinded, randomized clinical trial will test hypotheses by administering a single epidural injection prior to wound closure of either Ropivaciane® or saline.All pre-surgical activities and anesthesia will proceed as usual, with the addition of a single epidural injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal level. Experimental groups will receive 0.2% Ropivaciane® (10 ml; dose shown to be effective without transient weakness), 9 and the control group will receive 0.9% saline solution (10 ml). Accurate placement into the space will be verified by the injection of contrast medium (iohexol, 180 mgl/ml) under fluoroscopic guidance. Epidural solutions will be prepared prior to surgery by pharmacy and coded; surgeons will administer according to the patient's code maintaining the double-blind procedure. It is important to note that treatment as usual differs between open and MIS cohorts. The question of interest is whether the addition of the epidural analgesic to current practices for each surgery type results in increased positive outcomes, whether this is due to synergistic effects or not. Following operative treatment, Foley Urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically indicated.
Conditions
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Pain, Postoperative
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Randomization of arms are conducted by the pharmacy department, and drug or saline preparation are prepared by the pharmacy department.
Study Groups
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Experimental
Administration of epidural Ropivaciane
Group Type
EXPERIMENTAL
Ropivacaine
Intervention Type
DRUG
Administration of Ropivaciane via epidural injection intra-operatively
Control
Administration of saline
Group Type
PLACEBO_COMPARATOR
Saline
Intervention Type
OTHER
Administration of saline via epidural injection intra-operatively
Interventions
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Ropivacaine
Administration of Ropivaciane via epidural injection intra-operatively
Intervention Type
DRUG
Saline
Administration of saline via epidural injection intra-operatively
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada East Spine Centre
Exclusion Criteria
* History of severe respiratory, renal or hepatic disease
* Previous spine surgery
* Known allergy to local anaesthesia
* Those who experience dural tear during operative procedure
* Previous spine surgery
* Known allergy to local anaesthesia
* Those who experience dural tear during operative procedure
Minimum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Horizon Health Network
OTHER
Sponsor Role
lead
Responsible Party
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Dr. neil Manson
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Neil A Manson, MD FRCSC
Role: PRINCIPAL_INVESTIGATOR
Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
Edward P Abraham, MD FRCSC
Role: PRINCIPAL_INVESTIGATOR
Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
Central Contacts
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References
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Other Identifiers
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2016-2380
Identifier Type: -
Identifier Source: org_study_id
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