Poznan University of Medical Sciences
The study aims to assess the interfacial plane blocks' effect on pain level, course of postoperative rehabilitation, and anti-inflammatory analgesic effect.
Spine Fusion
Spine Disease
Spinal Disease
0.9%sodium chloride
0.2% ropivacaine
Phase 4
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.
| Study Type : | Interventional |
| Estimated Enrollment : | 60 participants |
| Masking : | Triple |
| Primary Purpose : | Treatment |
| Official Title : | Erector Spinae Plane Block for Cervical Spine Surgery. A Prospective, Randomized, Double-blinded Clinical Trial. |
| Actual Study Start Date : | May 1, 2024 |
| Estimated Primary Completion Date : | May 30, 2025 |
| Estimated Study Completion Date : | June 30, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Sham Comparator: Sham group Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline |
Drug: 0.9%sodium chloride |
|
Active Comparator: ESPB group Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0.2% Ropivacaine |
Drug: 0.2% ropivacaine |
| Ages Eligible for Study: | 18 Years to 100 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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Poznan University of Medical Sciences
Poznan, Poznań, Poland, 61-701