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

NCT03035656 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2019-02-21

No results posted yet for this study

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®.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Ropivacaine

Administration of Ropivaciane via epidural injection intra-operatively

OTHER

Saline

Administration of saline via epidural injection intra-operatively

Sponsors & Collaborators

  • Horizon Health Network

    lead OTHER

Principal Investigators

  • Neil A Manson, MD FRCSC · Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery

  • Edward P Abraham, MD FRCSC · Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2022-03-01
Completion
2022-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035656 on ClinicalTrials.gov