A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks

January 23, 2016 updated by: De QH Tran, Montreal General Hospital

A Randomized Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks

In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. In the current randomized trial, we will set out to compare conventional and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease the failure rate of thoracic epidural blocks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital, McGill University
  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Ramathibodi Hospital, Mahidol University

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the patients undergoing thoracic epidural catheter insertion for thoracic and abdominal surgery or rib fractures with American Society of Anesthesiologists (ASA) classification 1-3 and body mass index between 18 and 35

Exclusion Criteria:

  • adults who are unable to give their own consent
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, or International Normalized Ratio ≥ 1.4)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
  • allergy to local anesthetic (LA)
  • pregnancy
  • prior surgery in the thoracic spine

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional loss-of-resistance
Experimental: Waveform-confirmed loss-of-resistance
Procedure: Waveform-confirmed loss-of-resistance
Using waveform analysis to confirm thoracic epidural space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Successful Epidural Blocks
Time Frame: up to 15 minutes after the procedure
Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.
up to 15 minutes after the procedure

Collaborators and Investigators

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

Sponsor

Montreal General Hospital

Investigators

  • Principal Investigator: De QH Tran, McGill University

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

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 23, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-077 MUHC

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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