Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery

May 21, 2020 updated by: Georges Samouri, Clinique Saint Pierre Ottignies

Impact of the Erector Spinae Plane Block on the Postoperative Pain After Lumbar Spinal Stenosis Surgery: Single Blind Randomized Controlled Trial

Lumbar spinae stenosis surgery is a frequent intervention resulting in important postoperative pain. Management of this postoperative pain is thus important. Different pain management therapies exist. The erector spinae plane (ESP) block was described in 2016. It involves the injection of local anesthetics into the interfascial plane, deep to erector spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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

  • Belgium
    • Brabant Wallon
      • Ottignies, Brabant Wallon, Belgium, 1340

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Any lumbar spinae surgery on 2 or more lumbar levels

Exclusion Criteria:

  • Contraindication to NSAID
  • Allergy to any local anesthetics

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector Spinae plane Block (ESPB) group
The ultrasound-guided ESPB was realized at T12 level (levo bupivacaine 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)after the induction of anesthesia but before the start of the surgery.
Procedure: ESPB
Ultrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery
Active Comparator: Local anesthesia infiltration by the surgeon
The surgeon infiltrates the surgical site after skin incision with local anesthetics (Levo Bupivacaïne 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)
Procedure: Local infiltration by the surgeon
Local infiltration of anesthetics at surgical site after skin incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total 24 h Piritramide consumption
Time Frame: 24 hours
Total consumption of Piritramide consumption after surgery
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quebec back pain disability scale (QBPDS)
Time Frame: At 2 months]
A questionnaire developed to measure the level of functional disability for patients with low back pain
At 2 months]

Collaborators and Investigators

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

Sponsor

Clinique Saint Pierre Ottignies

Investigators

  • Principal Investigator: Georges SAMOURI, MD, Clinique Saint Pierre Ottignies

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)

October 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B707201837276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All data will be presented in future manuscripts.

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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