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Completed

NCT Number: NCT06393530

Erector Spinae Plane Block for Cervical Spine Surgery

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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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9%sodium chloride

Drug

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

Other names: 0,9% normal saline

0.2% ropivacaine

Drug

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

Other names: 0,2% ropivacaine

Primary outcomes

  1. first need of opiate

    Time frame: 48 hours

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

Secondary outcomes

  1. Opioid consumption

    Time frame: 48 hours

    Total opiate consumption after surgery

  2. Numerical Rating Scale [range 0:10]

    Time frame: 4 hours after surgery

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  3. Numerical Rating Scale [range 0:10]

    Time frame: 8 hours after surgery

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  4. Numerical Rating Scale [range 0:10]

    Time frame: 12 hours after surgery

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  5. Numerical Rating Scale [range 0:10]

    Time frame: 16 hours after surgery

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  6. Numerical Rating Scale [range 0:10]

    Time frame: 20 hours after surgery

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  7. Numerical Rating Scale [range 0:10]

    Time frame: 24 hours after surgery

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  8. Numerical Rating Scale [range 0:10]

    Time frame: 36 hours after surgery

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  9. Numerical Rating Scale [range 0:10]

    Time frame: 48 hours after surgery

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  10. NLR

    Time frame: 12 hours after surgery

    Neutrophil-to-lymphocyte ratio

  11. NLR

    Time frame: 24 hours after surgery

    Neutrophil-to-lymphocyte ratio

  12. NLR

    Time frame: 48 hours after surgery

    Neutrophil-to-lymphocyte ratio

  13. PLR

    Time frame: 12 hours after surgery

    Platet-to-lymphocyte ratio

  14. PLR

    Time frame: 24 hours after surgery

    Platet-to-lymphocyte ratio

  15. PLR

    Time frame: 48 hours after surgery

    Platet-to-lymphocyte ratio

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 1, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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