Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery

February 19, 2024 updated by: Ariane Clairoux, Ciusss de L'Est de l'Île de Montréal

Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery : A Multi-Center Randomized Controlled Trial

Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A growing number of thoracic surgeries are performed with a minimally invasive approach called video-assisted thoracoscopic surgery (VATS). VATS has reduced the incision size, the postoperative pain and the morbidity associated with thoracic surgery. Optimal postoperative analgesia for VATS surgery remains an open issue because although it is a lot less painful than a thoracotomy, VATS is a painful procedure with the associated risk of developing chronic pain. Adequate relief leads to early mobilization, potentially improves respiratory functions, and decreases the global stress response secondary to the surgery.

Invasive analgesic techniques such as epidural or paravertebral block for VATS surgery are frequently being replaced for less invasive plane blocks to provide postoperative analgesia. At our center, anesthesiologists tend to perform epidurals only when there is a significant risk of transitioning to an open thoracotomy. Patient controlled analgesia (PCA), remains the usual analgesic technique for VATS surgery at our institution.

Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

Study Type

Interventional

Enrollment (Actual)

52

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 Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Patients > 18 years old with to ASA status I-III, undergoing VATS for lobectomy or wedge.

Non-inclusion Criteria:

  • < 18 years old
  • BMI > 35
  • Chronic pain history with regular opioid and/or gabapentinoids use during the 2 weeks before surgery
  • Regular marijuana use
  • History of thoracic surgery on the operated side
  • Epidural analgesia preferred due to an anticipated high risk of conversion to thoracotomy
  • Unable to communicate with the investigators
  • Receiving anticoagulation or experiencing any bleeding disorder
  • Surgery for empyema and sympathectomy
  • Known allergy to local anesthetics, fentanyl or hydromorphone
  • Active infection at injection sites
  • Preexisting neurological deficit or psychiatric illness
  • Severe cardiovascular disease
  • Liver failure
  • Renal failure (estimated glomerular filtration rate <15 mL/ min/1.73 m2)
  • Pregnancy

Exclusion Criteria:

  • Perioperative conversion to thoracotomy
  • Severe intra- or postoperative bleeding
  • Patients requiring postoperative mechanical ventilation
  • Technical inability to proceed with the blocks

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
Active Comparator: ESP with Bupivacaine 0.5%

The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist.

Thirty milliliters of bupivacaine at a concentration of 0.5% with epinephrine 1:200 000 will be injected depending on the patient's allocation.

Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU).
Procedure: ESP with Bupivacaine 0.5%
Regional anesthesia procedure with Bupivacaïne 0.5%
Sham Comparator: ESP with Saline 0.9%

The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist.

Thirty milliliters of a placebo solution (normal saline) will be injected depending on the patient's allocation.

Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU).
Procedure: ESP with Saline 0.9%
Regional anesthesia procedure with Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hydromorphone consumption
Time Frame: 24 hours.
Using the Patient-Controlled Analgesia pumps, we will be able to calculate the amount of Hydromorphone that will be consumed by patients in each of our intervention arms.
24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thorax visual analog pain scores (VAS) : scale 0 (no pain) to 10 (worst)
Time Frame: 1-6-12-18-24 hours.
Using a regular 1 to 10 visual analog chart, post-surgery.
1-6-12-18-24 hours.
Total opioid consumption post-surgery
Time Frame: 1-6-12-18-24 hours.
Using the Patient-Controlled Analgesia pumps, we will be able to calculate the amount of Hydromorphone that will be consumed by patients in each of our intervention arms.
1-6-12-18-24 hours.
PONV Score : 1 to 3 (1- No nausea, 2- Nausea, 3- Vomiting)
Time Frame: 1-6-12-18-24 hours.
PONV Score (3 points).
1-6-12-18-24 hours.
Ramsay Sedation Scale (RSS) 1 to 6 (1- Awake and Agitated, 2- Awake but calm to 6- Asleep and no response to loud auditory stimulus)
Time Frame: 1-6-12-18-24 hours.

Sedation score of patients : Ramsay Sedation Scale (6 points).

  1. Awake ; agitated or restless or both.
  2. Awake ; cooperative, oriented, and tranquil.
  3. Awake but responds to commands only.
  4. Asleep ; brisk response to light glabellar tap or loud auditory stimulus.
  5. Asleep ; sluggish response to light glabellar tap or loud auditory stimulus.
  6. Asleep ; no response to glabellar tap or loud auditory stimulus.
1-6-12-18-24 hours.
Global QoR-15 score : 0 to 150 (worst to best)
Time Frame: Pre and postoperatively
QoR-15 Score is a score concerning the Quality of Recuperation post-surgery containing 15 questions with scales 0 to 10 (worst to best). The same questions are also asked before the surgery to understand the impact of the surgery and anesthesia.
Pre and postoperatively
Amount of intraoperative Fentanyl use
Time Frame: Intraoperatively
Amount in micrograms
Intraoperatively

Collaborators and Investigators

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

Sponsor

Ciusss de L'Est de l'Île de Montréal

Investigators

  • Principal Investigator: Ariane Clairoux, MD, Maisonneuve-Rosemont Hospital / CIUSSS de l'Est-de-l'Île-de-Montréal

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)

November 29, 2018

Primary Completion (Actual)

December 16, 2021

Study Completion (Actual)

December 16, 2021

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-12-2019-1640

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Protected health information will not be re-used or disclosed to a third party except as required by law, for authorized oversight of the research, or as permitted by an authorization signed by the research subject.

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.

Yes

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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