Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery

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: Lumbar Spinal Stenosis; Erector Spinae Plane Block
• Intervention / Treatment: Procedure: ESPB; Procedure: Local infiltration by the surgeon

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brabant Wallon
    • Ottignies, Brabant Wallon, Belgium, 1340
      • Recruiting
      • Clinique Saint Pierre
      • Contact: Georges SAMOURI, MD; Phone Number: 003210437260; Email: georges.samouri@cspo.be
      • Contact: Nicolas PARISI, MD; Phone Number: 003210437608; Email: nicolas.parisi@cspo.be

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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	Total consumption of Piritramide consumption after surgery	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Study record dates

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: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• 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