Erector Spinae Plane Block for Cervical Spine Surgery

NCT06393530 — Phase 4, Completed, 60 participants, Poznan University of Medical Sciences

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

RegistryNCT06393530
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment60 (Actual)
SponsorPoznan University of Medical Sciences (Other)
ConditionsSpine Fusion, Spine Disease, Spinal Disease
Interventions0.9%sodium chloride, 0.2% ropivacaine (Drug)
Datesstart 2024-07-15, primary completion 2025-12-30, completion 2026-01-17, first posted 2024-05-01, last updated 2026-02-02
Locations1 site in Poland

Related Papers Related Patents Related Grants Related Experts
All trials for Spine Fusion All trials for Spine Disease All trials of 0.9%sodium chloride All trials of 0.2% ropivacaine

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Sham groupSham comparatorDrug: 0.9%sodium chlorideBilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline
ESPB groupActive comparatorDrug: 0.2% ropivacaineBilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0.2% Ropivacaine
  • 0.9%sodium chloride (Drug), also known as 0,9% normal saline: Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline
  • 0.2% ropivacaine (Drug), also known as 0,2% ropivacaine: Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,2% ropivacaine

+Outcome measures

Primary outcomes

  • first need of opiate [48 hours]: Time after surgery when the patient needs opiate for the first time

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 100 Years

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

+Locations (1)

FacilityCityCountryStatus
Poznan University of Medical SciencesPoznan, PoznańPoland

+Investigators