Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation

NCT ID: NCT05220813

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-05-31

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).

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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local anesthetic group (control group)

44 patients will receive local infiltration anesthesia.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

local infiltration by lidocaine in the surgical site

ilioinguinal iliohypogastric group

44patients will receive ilioinguinal iliohypogastric nerve blocks

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

44patients will receive bupivacaine in ilioinguinal \& iliohypogastric nerve blocks

Interventions

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Lidocaine

local infiltration by lidocaine in the surgical site

Intervention Type DRUG

Bupivacain

44patients will receive bupivacaine in ilioinguinal \& iliohypogastric nerve blocks

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ismail Mohammed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ismail Mohammed Ibrahim

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ismail M ibrahim, MD

Role: CONTACT

+20224662448 ext. 002

mohamed mohsen mohamed, MD

Role: CONTACT

00201204227780 ext. 002

Facility Contacts

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ismail M ibrahim

Role: primary

0224662448

Other Identifiers

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FMASU R 187/2021

Identifier Type: -

Identifier Source: org_study_id

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