Erector Spinae Plane Block for Cervical Spine Surgery

NCT06393530 | Completed Phase 4

• 1 other identifier: 545/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spine Fusion; Spine Disease; Spinal Disease

Outcome Measures

Primary Outcomes (1)

• first need of opiate

  Time after surgery when the patient needs opiate for the first time

  48 hours

Secondary Outcomes (15)

• Opioid consumption

  48 hours

• Numerical Rating Scale [range 0:10]

  4 hours after surgery

• Numerical Rating Scale [range 0:10]

  8 hours after surgery

• Numerical Rating Scale [range 0:10]

  12 hours after surgery

• Numerical Rating Scale [range 0:10]

  16 hours after surgery

Study Arms (2)

Sham group

SHAM COMPARATOR

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

Drug: 0.9%sodium chloride

ESPB group

ACTIVE COMPARATOR

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

Drug: 0.2% ropivacaine

Interventions

0.9%sodium chloride DRUG

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

Also known as: 0,9% normal saline

Sham group

0.2% ropivacaine DRUG

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

Also known as: 0,2% ropivacaine

ESPB group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

Location

MeSH Terms

Conditions

Spinal Diseases

Interventions

Sodium Chloride; Ropivacaine

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Malgorzata Domagalska, Ph.D.

  Poznań University of Medical Science

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: July 15, 2024
• Primary Completion: December 30, 2025
• Study Completion: January 17, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)