Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation

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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: ismail M ibrahim, MD; Phone Number: 002 +20224662448; Email: doc_ismail_2006@yahoo.com
• Study Contact Backup: Name: mohamed mohsen mohamed, MD; Phone Number: 002 00201204227780

Study Locations

• Egypt
  • Cairo, Egypt, 11765
    • Recruiting
    • Ismail Mohammed Ibrahim
    • Contact: ismail M ibrahim; Phone Number: 0224662448; Email: doc_ismail_2006@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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: local anesthetic group (control group); 44 patients will receive local infiltration anesthesia.	Drug: Lidocaine; local infiltration by lidocaine in the surgical site
Active Comparator: ilioinguinal iliohypogastric group; 44patients will receive ilioinguinal iliohypogastric nerve blocks	Drug: Bupivacain; 44patients will receive bupivacaine in ilioinguinal & iliohypogastric nerve blocks

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: January 22, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

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: FMASU R 187/2021

Drug and device information, study documents

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