Erector Spinae Plane Block for Cervical Spine Surgery

Phase 4

Recruiting

• Conditions: Spine Fusion; Spinal Disease; Spine Disease
• Interventions: Drug: 0.2% ropivacaine; Drug: 0.9%sodium chloride

• Registration Number: NCT06393530
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-05-01
• Study Start: 2024-07-15
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESPB group	0.2% ropivacaine	Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0.2% Ropivacaine
Sham group	0.9%sodium chloride	Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline

Primary Outcome Measures

Name	Time	Method
first need of opiate	48 hours	Time after surgery when the patient needs opiate for the first time

Secondary Outcome Measures

Name	Time	Method
NLR	48 hours after surgery	Neutrophil-to-lymphocyte ratio
PLR	48 hours after surgery	Platet-to-lymphocyte ratio
Opioid consumption	48 hours	Total opiate consumption after surgery
Numerical Rating Scale [range 0:10]	48 hours after surgery	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poznań, Poland