Erector Spinae Plane Block in Lumbar Release Surgery (MERLIBERTION)

November 29, 2023 updated by: Clinique Saint Jean, France

Erector Spinae Plane Block in Lumbar Release Surgery : Double-blind, Randomized Controlled Trial

The aim of this study is to observe or not a reduction in the consumption of morphine within 72 hours of the realization of an erector spinae plane block when preparing for a non-instrumented spine surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Posterior lumbar spine surgery is surgery described by patients as painful. While fusion surgery seems more painful than simple release surgery, release surgery remains a painful surgery for patients. The management of post-operative pain is therefore a priority for anesthesiological-surgical teams.

Multimodal analgesia, already recognized for other surgeries, is one of the keys to success, combining oral analgesics and regional local anesthetics.

The recourse to the realization of a block of the erector muscles of the spine was described for the first time in 2016, it is described there in the literature as not presenting any particular risk, simple to apply and having a satisfactory analgesia action. However, this process is little described in the context of spine surgery and even less in the context of randomized controlled trials.

The investigator therefore hypothesize that the realization of a block of the erector muscles of the spine, because of its satisfactory analgesia action mentioned above, will decrease the consumption of postoperative morphine and at the same time reduce the side effects due to the latter.

On the other hand, no study has evaluated the effectiveness of spinal block as part of an Enhanced Rehabilitation After Surgery (RAAC) program. Indeed, the effectiveness of this practice has already been proven in a context of conventional care, but to date no studies have been carried out in the context of care involving the original elements of the RAAC, such as rapid mobilization and multimodal oral analgesia, which could impact the effectiveness of the erector muscle blocks of the spine.

At the Clinique Saint Jean Sud de France, the management of spine surgeries is part of this Improved Rehabilitation After Surgery (RAAC) process, which is why it seemed relevant to the investigator to carry out a randomized, controlled study. , double-blind to assess the consumption of postoperative morphine during the 72 hours following a lumbar arthrodesis in this context of care.

Study Type

Interventional

Enrollment (Actual)

100

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

  • France
      • Saint-Jean-de-Védas, France, 34430
        • Clinique Saint Jean

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:

  • Patient with medical insurance.
  • Patient twho received information about study and signes a consent to participate in the study.
  • Major patient to be operated on for lumbar release surgery without arthrodesis or osteosynthesis posterior (herniated disc repair, one or two level recalibration, laminectomy) +/- implant interlaminar.
  • Patient with an ASA score of 1, 2 or 3.

Exclusion Criteria:

  • Minor patient.
  • Patient with morphine intolerance
  • Patient with allergy to local anesthetics.
  • Patient consuming morphine for more than 3 months.
  • Pregnant or breastfeeding patient.
  • Patient scheduled for cancer surgery or trauma surgery.
  • Patient participating in another interventional study.
  • Patient with a history of lumbar arthrodesis.
  • Patient requiring lumbar surgery with arthrodesis.
  • Patient refusing to sign the consent form.
  • Patient for whom it is impossible to give informed information.
  • Patient under the protection of justice, under curatorship or under tutorship.

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
Experimental: Block
The "Block" group will be made up of patients who will benefit from an injection of levopubivacaïne for the realization of the erector spinae plane block.
Procedure: Erector spinae plane block

After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected.

Drug : Levobupivacaïne 2,5mg/ml.

Procedure: Erector spinae plane block

After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected.

Drug : NaCL 0,9%.
Placebo Comparator: Placebo
The "Placebo" group corresponds to the reference group, that is to say that it will consist of patients who benefit from an injection of physiological serum for the realization of the erector spinae plane block.
Procedure: Erector spinae plane block

After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected.

Drug : Levobupivacaïne 2,5mg/ml.

Procedure: Erector spinae plane block

After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected.

Drug : NaCL 0,9%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Consumption of postoperative morphine within 72 hours of the operation
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digital visual scale to assess pain of patient within 72 hours of the operation.
Time Frame: 72 hours
Numeric scale numbered from 0 to 10. 0 : no pain, 10 : worst pain possible.
72 hours
Onset of nausea and vomiting within 72 hours of the operation.
Time Frame: 72 hours
Onset of nausea/vomiting or taking an anti-vomiting treatment within 72 hours of the operation.
72 hours
Onset of complication within 30 days of the operation.
Time Frame: 30 days
30 days
Walking perimeter measurement by the physiotherapist during the 72 hours following the intervention.
Time Frame: 72 hours
Measurement of the maximum distance traveled without stopping in meter with or without assistance.
72 hours

Collaborators and Investigators

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

Sponsor

Clinique Saint Jean, France

Investigators

  • Principal Investigator: Guillaume LONJON, MD, Clinique Saint Jean, Saint Jean de Védas

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)

January 3, 2022

Primary Completion (Actual)

December 19, 2022

Study Completion (Actual)

December 19, 2022

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL2020-GL02

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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