Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery

NCT04403360 | Unknown DMC

• 1 other identifier: B707201837276
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Spinal Stenosis; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• Total 24 h Piritramide consumption

  Total consumption of Piritramide consumption after surgery

  24 hours

Secondary Outcomes (1)

• Quebec back pain disability scale (QBPDS)

  At 2 months]

Study Arms (2)

Erector Spinae plane Block (ESPB) group

EXPERIMENTAL

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

Local anesthesia infiltration by the surgeon

ACTIVE COMPARATOR

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

Interventions

ESPB PROCEDURE

Ultrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery

Erector Spinae plane Block (ESPB) group

Local infiltration by the surgeon PROCEDURE

Local infiltration of anesthetics at surgical site after skin incision

Local anesthesia infiltration by the surgeon

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Any lumbar spinae surgery on 2 or more lumbar levels

You may not qualify if:

• Contraindication to NSAID
• Allergy to any local anesthetics

Sponsors & Collaborators

• Clinique Saint Pierre Ottignies: lead

Study Sites (1)

Clinique Saint Pierre

Ottignies, Brabant Wallon, 1340, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 27501016 RESULT

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Georges SAMOURI, MD

  Clinique Saint Pierre Ottignies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georges SAMOURI, MD

CONTACT

003210437260; georges.samouri@cspo.be

Nicolas PARISI, MD

CONTACT

003210437608; nicolas.parisi@cspo.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Georges Samouri M.D.

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: October 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: April 1, 2021
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)