Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy

August 20, 2024 updated by: Eric Albrecht
The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients scheduled for thoracoscopy
  • physical status I-III

Exclusion Criteria:

  • allergy to local anaesthetics
  • other contraindications to peripheral nerve blocks
  • patients suffering from chronic pain condition

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Procedure: No injection
No injection
Experimental: Erector spinae plane block
Procedure: Erector spinae plane block
Injection of local anaesthetics below the erector spinae muscle after induction of anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IV morphine consumption
Time Frame: 24 postoperative hours
mg
24 postoperative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IV morphine consumption
Time Frame: 2 postoperative hours
mg
2 postoperative hours
IV morphine consumption
Time Frame: 48 postoperative hours
mg
48 postoperative hours
Pain scores
Time Frame: 2, 24, 24 postoperative hours
Visual analog scale, 0-10
2, 24, 24 postoperative hours
Chronic pain scores
Time Frame: 3 and 6 postoperative months
Visual analog scale, 0-10
3 and 6 postoperative months
Forced vital capacity
Time Frame: 24 and 48 postoperative hours
L
24 and 48 postoperative hours

Collaborators and Investigators

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

Sponsor

Eric Albrecht

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)

February 1, 2018

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 2017-01772

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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