Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study)

NCT06362915 | Recruiting Phase 1

• 1 other identifier: FMASUR66/2024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to compare the effect of illiohypogastric and ilioinguinal nerve block with the local infiltration with lidocaine in patients undergoing TAVI

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Extra Demand of sedation

  Need for increments of narcotics or propofol will be recorded and collected at the end of the procedure.

  All through procedure

Secondary Outcomes (1)

• Patient and surgeon satisfaction

  all through the procedure

Study Arms (2)

Group A:Lidocaine group

ACTIVE COMPARATOR

will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1%

Drug: Lidocaine

Group B:Bupivacaine group

ACTIVE COMPARATOR

will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist

Drug: Bupivacain

Interventions

Lidocaine DRUG

* Group (A) lidocaine : will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1%.

Group A:Lidocaine group

Bupivacain DRUG

• Group (B),bupivacaine: will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivacaine 0.25% by an experienced anesthesiologist

Group B:Bupivacaine group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients fulfilling criteria for TAVI regarding age \& pathology of aortic valve will be included in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

maha sadek El Derh

Cairo, Heliopolis, 11721, Egypt

RECRUITING

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Lidocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

maha S El Derh, MD

CONTACT

01144866675; mahasadek81@yahoo.com

samar M Abd El Tawab, MD

CONTACT

01006236494

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Group (A): will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1% (9). * Group (B): will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: January 2, 2024
• Primary Completion: July 15, 2024
• Study Completion: August 30, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)