Ilioinguinal Nerve Block in Transcatheter Aortic Valve Im... | NCT05220813

Studies
Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation

NCT05220813

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Feb 21, 2022Actual

Enrollment

88Estimated

Phase

Phase 4

Conditions

Anesthesia

Interventions

Lidocaine
Bupivacain

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2021Actual

Primary Completion Date

May 2022Estimated

Completion Date

May 2022Estimated

First Submitted Date

Jan 22, 2022

First Submission Date that Met QC Criteria

Feb 1, 2022

First Posted Date

Feb 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2022

Last Update Posted Date

Feb 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
local anesthetic group (control group)	Active Comparator	44 patients will receive local infiltration anesthesia.	Drug: Lidocaine
ilioinguinal iliohypogastric group	Active Comparator	44patients will receive ilioinguinal iliohypogastric nerve blocks	Drug: Bupivacain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine	Drug	local infiltration by lidocaine in the surgical site	local anesthetic group (control group)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ismail M ibrahim, MD	Contact	+20224662448	002	doc_ismail_2006@yahoo.com
mohamed mohsen mohamed, MD	Contact	00201204227780	002

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ismail Mohammed Ibrahim	Recruiting	Cairo		11765	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

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Browse Branches

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