Erector Spinae Plane Block for Cervical Spine Surgery

Poznan University of Medical Sciences (PUMS)

Status and phase: Enrolling; Phase 4

Conditions: Spine Fusion; Spinal Disease; Spine Disease

Treatments: Drug: 0.9%sodium chloride; Drug: 0.2% ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06393530

545/23

Details and patient eligibility

About

The study aims to assess the interfacial plane blocks' effect on pain level, course of postoperative rehabilitation, and anti-inflammatory analgesic effect.

Full description

This study evaluates the analgesic efficacy in adults of bilevel, bilateral erector spinae plane (ESP) blocks after posterior cervical spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing primary posterior cervical decompression and stabilization with instrumentation involving multi-levels in the cervical region,
• aged >18 years and <100 years
• ASA physical status 1, 2 or 3.

Exclusion criteria

• refuse to participate,
• history of opioid abuse,
• infection of the puncture site,
• aged <18 years and >100 years
• ASA 4 and 5

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Sham group

Sham Comparator group

Description:

Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline

Treatment:

Drug: 0.9%sodium chloride

ESPB group

Active Comparator group

Description:

Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0.2% Ropivacaine

Treatment:

Drug: 0.2% ropivacaine