Comparing ultrasound and surgical methods for pain relief in lumbar fusion surgery
Efficacy of Ultrasound-guided Versus Surgical Erector Spinae Plane Block With a Mixture of Bupivacaine and Dexmedetomidine in Lumbar Spinal Fusion Surgery: A Prospective Randomized Double-Blinded Clinical Trial.
This study is testing whether using ultrasound to guide a pain relief technique works better than the traditional surgical method for patients recovering from back surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fayoum University Hospital Academic / other |
| Locations | 1 site (Fayoum, Fayoum Governorate) |
| Trial ID | NCT06958718 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of ultrasound-guided erector spinae plane block (UB) versus surgical erector spinae plane block (SB) in managing postoperative pain for patients undergoing elective lumbar spinal fusion surgeries. Patients will be randomly assigned to one of the two groups, and both the anesthesiologist and the patient will be blinded to the group assignments to ensure unbiased results. The study will assess pain relief and opioid consumption post-surgery, with the goal of improving pain management strategies and reducing complications associated with traditional opioid-based treatments.
Who should consider this trial
Good fit: Ideal candidates are ASA I-III patients scheduled for elective two or three-level lumbar spinal fusion surgeries.
Not a fit: Patients with significant comorbidities, contraindications to regional anesthesia, or those undergoing emergent surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques that reduce reliance on opioids and enhance recovery after lumbar fusion surgery.
How similar studies have performed: Previous studies have shown promise in using regional nerve blocks for postoperative pain management, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - American Society of Anesthesiologists (ASA) I-Ⅲ patients scheduled for elective two or three levels of lumbar spinal fusion surgeries by the same surgical team. Exclusion Criteria: * Patient refusal. * Body mass index \> 30 kg/m2 * Significant renal, hepatic, or cardiovascular diseases. * History of allergy to one of the study drugs (local anesthetics, opioids, or dexmedetomidine). * Any contraindications to regional anesthesia like local infection or abnormal coagulation function. * Pregnant or breastfeeding women. * Chronic opioid use, history of chronic pain, or cognitive disorders. * Emergent surgeries.
Where this trial is running
Fayoum, Fayoum Governorate
- Fayoum University hospital — Fayoum, Fayoum Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed A Hamed, MD — Fayoum University Hospital
- Study coordinator: Doaa SH Nageh, Bch
- Email: ds1567@fayoum.edu.eg
- Phone: 10 16991443
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.