Clinical trial NCT06393530: Erector Spinae Plane Block for Cervical Spine Surgery
Official title: Erector Spinae Plane Block for Cervical Spine Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Spine Fusion
Spine Disease
Spinal Disease
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: first need of opiate
timeFrame: 48 hours
Secondary outcomes:
measure: Opioid consumption
timeFrame: 48 hours
measure: Numerical Rating Scale [range 0:10]
timeFrame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 16 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 20 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 24 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 36 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 48 hours after surgery
measure: NLR
timeFrame: 12 hours after surgery
measure: NLR
timeFrame: 24 hours after surgery
measure: NLR
timeFrame: 48 hours after surgery
measure: PLR
timeFrame: 12 hours after surgery
measure: PLR
timeFrame: 24 hours after surgery
measure: PLR
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
Study officials:
affiliation: Poznań University of Medical Science
name: Malgorzata Domagalska, Ph.D.
role: STUDY_CHAIR
References: