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
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Ropivacaine Other: Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||228 participants|
|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|
Administration of epidural Ropivaciane
Administration of Ropivaciane via epidural injection intra-operatively
Placebo Comparator: Control
Administration of saline
Administration of saline via epidural injection intra-operatively
- 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.
- 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).
- 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)
- 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.
- 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.
- 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
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
|Contact: Erin E Bigney, BA MA||506 648 firstname.lastname@example.org|
|Contact: Eden A Richardson, BA||506 648 6116||Eden.Richardson@Horizonnb.ca|
|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|