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Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion

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ClinicalTrials.gov Identifier: NCT03035656
Recruitment Status : Not yet recruiting
First Posted : January 30, 2017
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. neil Manson, Horizon Health Network

Brief Summary:
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®.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ropivacaine Other: Saline Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomization of arms are conducted by the pharmacy department, and drug or saline preparation are prepared by the pharmacy department.
Primary Purpose: Supportive Care
Official Title: Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Arm Intervention/treatment
Experimental: Experimental
Administration of epidural Ropivaciane
Drug: Ropivacaine
Administration of Ropivaciane via epidural injection intra-operatively

Placebo Comparator: Control
Administration of saline
Other: Saline
Administration of saline via epidural injection intra-operatively




Primary Outcome Measures :
  1. Change in Pain [ Time Frame: Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively ]
    Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain.


Secondary Outcome Measures :
  1. Change in Disability [ Time Frame: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively ]
    Measurement of disability attributed to "back problem" using the validated Oswestry Disability Index (ODI).

  2. Change in General Health [ Time Frame: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively ]
    Measurement of overall general health as measured by the validated Short Form General Health Survey (SF-12)

  3. Change in Medication Use [ Time Frame: Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively. ]
    Medication used to control pain post-operatively as given by a qualified health professional while the patient is in hospital.


Other Outcome Measures:
  1. Change in Ambulation [ Time Frame: Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively. ]
    The patient's ability to walk following surgery as measured using Ortho-Care Step Watch Activity Monitors (SAM) which will be attached to the patient's ankle during their stay in hospital.

  2. Adverse Events [ Time Frame: The total number of adverse events will be measured at the time of patient discharge, between 48 hours and 120 hours following surgical intervention ]
    Adverse Events (AEs) will be measured using the validated Spine Adverse



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03035656


Contacts
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Contact: Erin E Bigney, BA MA 506 648 6028 cescresearch@gmail.com
Contact: Eden A Richardson, BA 506 648 6116 Eden.Richardson@Horizonnb.ca

Sponsors and Collaborators
Horizon Health Network
Investigators
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Principal Investigator: Neil A Manson, MD FRCSC Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
Principal Investigator: Edward P Abraham, MD FRCSC Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery

Publications:

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Responsible Party: Dr. neil Manson, Principal Investigator, Horizon Health Network
ClinicalTrials.gov Identifier: NCT03035656     History of Changes
Other Study ID Numbers: 2016-2380
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared. Study results will be made available following data analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. neil Manson, Horizon Health Network:
Pain
analgesic
spinal fusion

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents