Using a specific nerve block technique to improve anesthesia for spinal surgery
Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations
This study is testing a new nerve block technique to see if it can improve pain management for patients having surgery to fix spinal deformities compared to regular anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 12 Years to 90 Years |
| Sex | All |
| Sponsor | Lviv National Medical University Academic / other |
| Locations | 1 site (Rivne, Rivne Region) |
| Trial ID | NCT04697498 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance anesthetic management for patients undergoing surgical correction of spinal deformities by incorporating a bilateral bi-level Erector spine plane block alongside general anesthesia. Patients will be monitored throughout various stages of the surgical process, including preoperative preparation and postoperative recovery, to assess pain management and overall outcomes. The study will compare the effectiveness of this nerve block technique against standard general anesthesia in managing acute and chronic pain. Comprehensive assessments will be conducted, including blood tests and evaluations of cardiovascular and respiratory systems.
Who should consider this trial
Good fit: Ideal candidates are patients with spinal deformities requiring surgical correction and who do not have allergies to local anesthetics.
Not a fit: Patients with diabetes mellitus, acute spinal cord injuries, or those classified as ASA III or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and recovery outcomes for patients undergoing spinal surgery.
How similar studies have performed: Other studies have shown promising results with similar regional anesthesia techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Informed consent of the patient or his legal representatives to participate the study. 2. Spinal deformity that requires surgical correction. 3. No known allergies to local anaesthetics. 4. Negative intradermal test for sensitivity to local anaesthetics. Exclusion Criteria: 1. Refusal of the patient or his legal representatives to participate the study 2. Diabetes mellitus, known allergy to local anaesthetics 3. Acute spinal cord injury 4. Physical status according to classification ASA III and more 5. A positive intradermal test for sensitivity to a local anaesthetic.
Where this trial is running
Rivne, Rivne Region
- Rivne Oblast State Hospital — Rivne, Rivne Region, Ukraine (Recruiting)
Study contacts
- Principal investigator: Maksym Barsa — Rivne Region Hospital
- Study coordinator: Maksym Barsa
- Email: maksymbarsa@gmail.com
- Phone: +380952074098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.