Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04403360
• Other study ID #: B707201837276
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: May 2020
• Source: Clinique Saint Pierre Ottignies
• Contact: Georges SAMOURI, MD
• Phone: 003210437260
• Email: georges.samouri[@]cspo.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Any lumbar spinae surgery on 2 or more lumbar levels

Exclusion Criteria:

• Contraindication to NSAID

• Allergy to any local anesthetics

Related Conditions & MeSH terms

• Constriction, Pathologic
• Erector Spinae Plane Block
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• ESPB
Ultrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery
• Local infiltration by the surgeon
Local infiltration of anesthetics at surgical site after skin incision

Locations

Country	Name	City	State
Belgium	Clinique Saint Pierre	Ottignies	Brabant Wallon

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint Pierre Ottignies

Country where clinical trial is conducted

Belgium, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total 24 h Piritramide consumption	Total consumption of Piritramide consumption after surgery	24 hours
Secondary	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]