Comparing nerve block techniques for pain management in TAVI procedures
Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study)
This study is testing whether two types of nerve blocks can help manage pain better than a local anesthetic during heart valve replacement procedures for patients.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 2 sites (Cairo, Heliopolis and 1 other locations) |
| Trial ID | NCT06362915 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized, double-blinded study aims to evaluate the analgesic effects of iliohypogastric and ilioinguinal nerve blocks compared to local infiltration with lidocaine in patients undergoing transcatheter aortic valve implantation (TAVI). The study will be conducted at Ain Shams University hospitals in Cairo, Egypt, with participants, care providers, and outcome assessors unaware of the treatment allocation. A total of 60 patients will be enrolled, and they will be randomly assigned to receive either nerve block or local infiltration for pain management during the procedure. The study will last for one year following ethical approval and informed consent from all participants.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who meet the criteria for TAVI based on age and aortic valve pathology.
Not a fit: Patients with neurological diseases, severe respiratory conditions requiring mechanical ventilation, or those with coagulation abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pain management strategies for patients undergoing TAVI, potentially leading to better patient outcomes and satisfaction.
How similar studies have performed: Other studies have shown success with nerve block techniques for pain management in various surgical procedures, suggesting potential efficacy in this context as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients fulfilling criteria for TAVI regarding age \& pathology of aortic valve will be included in the study. Exclusion Criteria: Refusal of the patients, Patients with neurological disease (Disturbed conscious level or psychiatric illness) severe respiratory disease need mechanical ventilation or need respiratory support, coagulation abnormalities, infection at site of injection.
Where this trial is running
Cairo, Heliopolis and 1 other locations
- maha sadek El Derh — Cairo, Heliopolis, Egypt (Recruiting)
- Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: maha S El Derh, MD
- Email: mahasadek81@yahoo.com
- Phone: 01144866675
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.