Erector Spinae Plane Block for Cervical Spine Surgery

Erector Spinae Plane Block for Cervical Spine Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.

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

Study Overview

• Status: Completed
• Conditions: Spine Fusion; Spine Disease; Spinal Disease
• Intervention / Treatment: Drug: 0.9%sodium chloride; Drug: 0.2% ropivacaine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Poznań
    • Poznan, Poznań, Poland, 61-701
      • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham group; Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline	Drug: 0.9%sodium chloride; Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline; Other Names: 0,9% normal saline
Active Comparator: ESPB group; Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0.2% Ropivacaine	Drug: 0.2% ropivacaine; Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,2% ropivacaine; Other Names: 0,2% ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Total opiate consumption after surgery	48 hours
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	4 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	8 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	12 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	16 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	20 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	24 hours after surgery
NLR	Neutrophil-to-lymphocyte ratio	48 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	36 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	48 hours after surgery
NLR	Neutrophil-to-lymphocyte ratio	12 hours after surgery
NLR	Neutrophil-to-lymphocyte ratio	24 hours after surgery
PLR	Platet-to-lymphocyte ratio	12 hours after surgery
PLR	Platet-to-lymphocyte ratio	24 hours after surgery
PLR	Platet-to-lymphocyte ratio	48 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Malgorzata Domagalska, Ph.D., Poznań University of Medical Science

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): January 17, 2026

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Ropivacaine; Sodium Chloride
• Other Study ID Numbers: 545/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No