Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery

Not Applicable

• Conditions: Erector Spinae Plane Block; Lumbar Spinal Stenosis
• Interventions: Procedure: ESPB; Procedure: Local infiltration by the surgeon

• Registration Number: NCT04403360
• Lead Sponsor: Clinique Saint Pierre Ottignies

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Last Update Submitted: 2020-05-21
• Study First Posted: 2020-05-27
• Last Update Posted: 2020-05-27
• Primary Completion: 2020-12-31
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Any lumbar spinae surgery on 2 or more lumbar levels

Exclusion Criteria

• Contraindication to NSAID
• Allergy to any local anesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae plane Block (ESPB) group	ESPB	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.
Local anesthesia infiltration by the surgeon	Local 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)

Primary Outcome Measures

Name	Time	Method
Total 24 h Piritramide consumption	24 hours	Total consumption of Piritramide consumption after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique Saint Pierre; 🇧🇪 Ottignies, Brabant Wallon, Belgium