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Erector Spinae Plane Block for Cervical Spine Surgery

P

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

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

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

Trial contacts and locations

1

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Central trial contact

Malgorzata Domagalska, Ph.D.

Data sourced from clinicaltrials.gov

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