Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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To assess the effect of iliohypogastric and ilioinguinal nerve block on the hemodynamic stability ,narcotic consumption and the rate of conversion to general anesthesia in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).

Official Title
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Does Ilioinguinal Block Provide Satisfactory Analgesia During Transcatheter Aortic Valve Implantation Procedure? A Comparative Study

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Bupivacain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients undergoing TF-TAVI. Both sexes. Age 18 and above Exclusion Criteria: • Inability to tolerate supine position as in patients with musculoskeletal disease or back pain, OR in patients with congestive heart failure or with obstructive sleep apnea. Patients with severe pulmonary hypertension (PAP>60 mmhg) Barrier to communications as language barrier or dementia. Patients' preference of general anesthesia. Surgical consideration as transapical, subclavian approach, extensive TEE requirements. Patients with history of allergy to any drugs used. Patients with psychiatric disease. Patients with neurocognitive or neurodegenerative disease. Secondary exclusion criteria include abortion of the procedure, perioperative emergency conversion to general anesthesia and the need to cardiopulmonary resuscitation so the primary endpoint couldn't be detected in these conditions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: local anesthetic group (control group)<br>44 patients will receive local infiltration anesthesia. | Drug: Lidocaine<br>* local infiltration by lidocaine in the surgical site<br>|
| Active Comparator: ilioinguinal iliohypogastric group<br>44patients will receive ilioinguinal iliohypogastric nerve blocks | Drug: Bupivacain<br>* 44patients will receive bupivacaine in ilioinguinal & iliohypogastric nerve blocks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion to general anesthesia. | Conversion to general anesthesia in other than procedure related causes. | during the procedure (intraoperatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| propofol dose | Total dose of propofol per hour (0.025-0.075 mg /kg/min) | during the procedure (intraoperatively) | 
| fentanyl dose | total dose of fentanyl 1-2 microgram / kg | during the procedure (intraoperatively) | 
| sedation score | sedation score intraoperatively | during the procedure (intraoperatively) |