Epidural Waveform Analysis for Thoracic Epidural Blocks

February 4, 2019 updated by: De Tran, McGill University Health Centre/Research Institute of the McGill University Health Centre

A Randomized Comparison Between Epidural Waveform Analysis Through the Needle Versus the Catheter for Thoracic Epidural Blocks

Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for loss-of-resistance (LOR): when the needle/catheter tip is correctly positioned inside the epidural space, pressure measurement results in a pulsatile waveform. Epidural waveform analysis can be carried out through the tip of the needle or the catheter. In this randomized trial, the objective is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The epidural space is most commonly identified with loss-of-resistance (LOR). Though sensitive Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for LOR. When the needle (or catheter) is correctly positioned inside the epidural space, pressure measurement at its tip results in a pulsatile waveform synchronized with arterial pulsations Currently, there exist two different methods for EWA. Since local anesthetic (LA) is administered through the catheter, pressure transduction through its tip ensures that it is properly positioned inside the epidural space prior to LA injection. Alternately, EWA can be performed through the needle prior to blind advancement of the epidural catheter.

Thus, in this randomized trial, the aim is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks. The hypothesis is that, compared to EWA-C, EWA-N will result in a shorter performance time.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

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

  • Chile
    • RM
      • Santiago, RM, Chile
        • Hospital Clinico Universidad de Chile
  • Thailand
      • Bangkok, Thailand
        • Ramathibodi Hospital

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 18 and 80 years
  • American Society of Anesthesiologists classification 1-3
  • body mass index between 20 and 35

Exclusion Criteria:

  • adults who are unable to give their own consent
  • coagulopathy
  • renal failure
  • hepatic failure
  • allergy to local anesthetic
  • 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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EWA through the needle
EWA through the needle group, 5 mL of normal saline are injected through the epidural needle after the occurrence of LOR. The needle is subsequently connected to the pressure transducer (leveled with the heart) via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations.
Device: EWA through the needle
In the EWA-N group, 5 mL of normal saline are injected through the epidural needle after the occurrence of loss-of-resistance (LOR). The needle is connected to the pressure transducer. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of normal saline through the epidural needle and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection, the operator removes the needle and reattempts the epidural block at a different intervertebral level. A maximum of 3 levels is permitted: if waveforms are still absent at the third level, the operator simply accepts LOR as the technical endpoint.
Experimental: EWA through the catheter
EWA through the catheter group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations.
Device: EWA through the catheter
In the EWA-C group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of saline through the catheter and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection are still absent at the third level, the operator simply accepts this position for catheter placement (intent-to-treat analysis).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance time of block
Time Frame: From skin infiltration until local anesthetic administration through the needle or catheter, up to 60 minutes
temporal interval in minutes between skin infiltration and local anesthetic administration through the epidural catheter (after obtaining a satisfactory waveform either through the needle or through the catheter depending on randomized group assignment).
From skin infiltration until local anesthetic administration through the needle or catheter, up to 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of successful epidural block
Time Frame: 15 minutes after the administration of local anesthetic through the epidural catheter
bilateral block to ice in at least 2 dermatomes
15 minutes after the administration of local anesthetic through the epidural catheter
Procedural pain during epidural block assessed by the numeric rating scale
Time Frame: From the performance of the epidural block until induction of general anesthesia, up to 2 hours
pain in the back of the patient, related to the performance of the epidural block, using a numeric rating scale from 0 to 10 points (0=no pain and 10= worst imaginable pain)
From the performance of the epidural block until induction of general anesthesia, up to 2 hours
Postoperative pain related to surgical incision assessed by the numeric rating scale
Time Frame: twice a day from the arrival at PACU or until catheter removal, up to 5 days
pain at rest and upon deep breathing/coughing, measured using a numeric rating scale from 0 to 10 points ((0=no pain and 10= worst imaginable pain)
twice a day from the arrival at PACU or until catheter removal, up to 5 days
Local anesthetic consumption
Time Frame: once a day from the arrival at PACU or until catheter removal, up to 5 days
amount of local anesthetic consumed
once a day from the arrival at PACU or until catheter removal, up to 5 days
Breakthrough opioid consumption (if required)
Time Frame: once a day from the arrival at PACU or until catheter removal, up to 5 days
amount of opioids consumed
once a day from the arrival at PACU or until catheter removal, up to 5 days
Incidence of adverse events
Time Frame: Once a day from catheter insertion until removal, up to 5 days
side effects related to the performance of the epidural block (eg, dural/vascular puncture, paresthesia) or breakthrough opioids (nausea, vomiting, pruritus, somnolence, respiratory depression)
Once a day from catheter insertion until removal, up to 5 days

Collaborators and Investigators

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Ramathibodi Hospital
University of Chile

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 (Actual)

July 30, 2018

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

February 2, 2019

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-4669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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