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

February 20, 2019 updated by: Dr. neil Manson, Horizon Health Network
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®.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
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)
Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
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.
Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.
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
The total number of adverse events will be measured at the time of patient discharge, between 48 hours and 120 hours following surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Horizon Health Network

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-2380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared. Study results will be made available following data analysis.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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