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Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery

C

Clinique Saint Pierre Ottignies

Status

Unknown

Conditions

Erector Spinae Plane Block
Lumbar Spinal Stenosis

Treatments

Procedure: ESPB
Procedure: Local infiltration by the surgeon

Study type

Interventional

Funder types

Other

Identifiers

NCT04403360
B707201837276

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Any lumbar spinae surgery on 2 or more lumbar levels

Exclusion criteria

  • Contraindication to NSAID
  • Allergy to any local anesthetics

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Erector Spinae plane Block (ESPB) group
Experimental group
Description:
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.
Treatment:
Procedure: ESPB
Local anesthesia infiltration by the surgeon
Active Comparator group
Description:
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)
Treatment:
Procedure: Local infiltration by the surgeon

Trial contacts and locations

1

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Central trial contact

Nicolas PARISI, MD; Georges SAMOURI, MD

Data sourced from clinicaltrials.gov

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