Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery

NCT ID: NCT04403360

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ESPB

Intervention Type: PROCEDURE

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

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)

Group Type: ACTIVE_COMPARATOR

Local infiltration by the surgeon

Intervention Type: PROCEDURE

Local infiltration of anesthetics at surgical site after skin incision

Interventions

ESPB

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

Intervention Type: PROCEDURE

Local infiltration by the surgeon

Local infiltration of anesthetics at surgical site after skin incision

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Any lumbar spinae surgery on 2 or more lumbar levels

Exclusion Criteria

• Contraindication to NSAID
• Allergy to any local anesthetics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique Saint Pierre Ottignies

OTHER

Sponsor Role: lead

Responsible Party

Georges Samouri

Georges Samouri M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georges SAMOURI, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Saint Pierre Ottignies

Locations

Clinique Saint Pierre

Ottignies, Brabant Wallon, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Georges SAMOURI, MD

Role: CONTACT

georges.samouri@cspo.be

003210437260

Nicolas PARISI, MD

Role: CONTACT

nicolas.parisi@cspo.be

003210437608

Facility Contacts

Georges SAMOURI, MD

Role: primary

georges.samouri@cspo.be

003210437260

Nicolas PARISI, MD

Role: backup

nicolas.parisi@cspo.be

003210437608

References

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.

Reference Type: RESULT

PMID: 27501016 (View on PubMed)

Other Identifiers

B707201837276

Identifier Type: -

Identifier Source: org_study_id