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

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

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: Lidocaine; Drug: Bupivacain

Detailed Description

This prospective, randomized, double blinded study will take place at cardiothoracic academy, Ain Shams University hospitals, Cairo, Egypt. In this study, participants, care providers and outcomes assessors will be ignorant of the treatment allocation. The study will start after obtaining the ethical approval & will continue for a 1 year. All patients will sign written informed consent before inclusion.

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.

After confirming the diagnosis & preoperative sizing of the valve by CT heart and then confirmation that no need for TEE guidance of the procedure, we will include 60 patients and then will be divided into two groups according to the technique of local anesthesia for the site of puncture.

Sample size calculation was done using G power program; setting power at 80% and α error at 5%, a sample size 52 patients undergoing transcatheter aortic valve implantation "TAVI" (26 patients receiving iliohypogastric with ilioinguinal nerve block and 26 patients receiving local infiltration with lidocaine) will be added to detect a statistically significant difference between the two groups as regard analgesic consumption, assuming a large effect size difference (dz=0.8)regarding Hasak et al.,2019. Patients will be randomly allocated into two equal groups each one made of 30 patients, the allocation ratio is 1:1 and the method of randomization will be computer generated randomized numbers, and it will be hidden in sealed opaque envelopes to conceal the allocation. The study will start after acquisition of ethical approval and expected to continue for a year.

• Group (A): will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1%.
• Group (B): will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist. (9).

In both group all patients undergo preoperative assessment: Full history, examination & investigations.

ECG, ECHO, CT heart and CT coronary angiography, LL venous & arterial duplex, CBC, Kidney and liver functions, Coagulation profile & carotid duplex.

Inside the catheterization room, for both groups after standard monitors and invasive hemodynamic monitors were applied (US guided arterial in left radial, CVC inserted in left IJV & sheath in right IJV for pacemaker).

Then Dexmedetomidine started in both groups by 0.1 up to 0.5 mic/kg/hour without loading with continuous monitoring for the HR and BP .

Then the patients divided into two groups: group for local infiltration and group for ilioinguinal illiohypogastric nerve block.

During injection of local anesthesia in both group any hemodynamic changes (blood pressure and heart rate should be closely monitored and recorded during data collection.

TAVI procedure will be proceeded. All patients were sent to ICU for postoperative care. HR, MAP, Conscious level of the patient assessed every 5 minutes. Need for increments narcotics or Propofol recorded and collected at end of procedure.

A Study made in 2019 on the effect of illiohypogastric ilioinguinal nerve block in TAVI patient found that Ultrasound-guided II-IH nerve block produce better intraoperative analgesia and less analgesic consumption than local infiltration anesthesia in patients undergoing TAVI .

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: maha S El Derh, MD; Phone Number: 01144866675; Email: mahasadek81@yahoo.com
• Study Contact Backup: Name: samar M Abd El Tawab, MD; Phone Number: 01006236494

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain shams university
    • Principal Investigator: maha S elDerh, Ass.prof
  • Heliopolis
    • Cairo, Heliopolis, Egypt, 11721
      • Recruiting
      • maha sadek El Derh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A:Lidocaine group; will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1%	Drug: Lidocaine; Group (A) lidocaine : will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1%.
Active Comparator: Group B:Bupivacaine group; will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist	Drug: Bupivacain; • Group (B),bupivacaine: will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivacaine 0.25% by an experienced anesthesiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and surgeon satisfaction	Patient satisfaction in form not complaining or asking for more analgesic or deepen anesthesia. Surgical satisfaction in form of quiet noncomplaining patient, hemodynamic stability	all through the procedure

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: FMASUR66/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No