Erector Spinae Plane Block for Cervical Spine Surgery

Spine Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393530
• Other study ID #: 545/23
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, Ph.D.
• Phone: +48 61 8738303
• Email: mdomagalska[@]ump.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Disease
• Spinal Diseases
• Spine Disease
• Spine Fusion

Intervention

Drug:
• 0.9%sodium chloride
Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline
• 0.2% ropivacaine
Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,2% ropivacaine

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours
Secondary	Opioid consumption	Total opiate consumption after surgery	48 hours
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	4 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	8 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	12 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	16 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	20 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	24 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	36 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	48 hours after surgery
Secondary	NLR	Neutrophil-to-lymphocyte ratio	12 hours after surgery
Secondary	NLR	Neutrophil-to-lymphocyte ratio	24 hours after surgery
Secondary	NLR	Neutrophil-to-lymphocyte ratio	48 hours after surgery
Secondary	PLR	Platet-to-lymphocyte ratio	12 hours after surgery
Secondary	PLR	Platet-to-lymphocyte ratio	24 hours after surgery
Secondary	PLR	Platet-to-lymphocyte ratio	48 hours after surgery