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

NCT03035656 | Unknown Phase 4 DMC

• 1 other identifier: 2016-2380
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

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®.

Conditions

Pain, Postoperative

Keywords

Pain; analgesic; spinal fusion

Outcome Measures

Primary Outcomes (1)

• Change in Pain

  Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain.

  Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively

Secondary Outcomes (3)

• Change in Disability

  Administered 6 weeks pre-operatively, 6 and 12 months post-operatively

• Change in General Health

  Administered 6 weeks pre-operatively, 6 and 12 months post-operatively

• Change in Medication Use

  Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.

Other Outcomes (2)

• Change in Ambulation

  Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.

• Adverse Events

  The total number of adverse events will be measured at the time of patient discharge, between 48 hours and 120 hours following surgical intervention

Study Arms (2)

Experimental

EXPERIMENTAL

Administration of epidural Ropivaciane

Drug: Ropivacaine

Control

PLACEBO COMPARATOR

Administration of saline

Other: Saline

Interventions

Ropivacaine DRUG

Administration of Ropivaciane via epidural injection intra-operatively

Experimental

Saline OTHER

Administration of saline via epidural injection intra-operatively

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada East Spine Centre

You may not qualify if:

• History of severe respiratory, renal or hepatic disease
• Previous spine surgery
• Known allergy to local anaesthesia
• Those who experience dural tear during operative procedure

Sponsors & Collaborators

• Horizon Health Network: lead

Related Publications (29)

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MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin E Bigney, BA MA

CONTACT

506 648 6028; cescresearch@gmail.com

Eden A Richardson, BA

CONTACT

506 648 6116; Eden.Richardson@Horizonnb.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization of arms are conducted by the pharmacy department, and drug or saline preparation are prepared by the pharmacy department.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 30, 2017
• Study Start: March 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share