Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation
Does Ilioinguinal Block Provide Satisfactory Analgesia During Transcatheter Aortic Valve Implantation Procedure? A Comparative Study
1 other identifier
interventional
88
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2021
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2021
CompletedFirst Submitted
Initial submission to the registry
January 22, 2022
CompletedFirst Posted
Study publicly available on registry
February 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedFebruary 21, 2022
February 1, 2022
6 months
January 22, 2022
February 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
conversion to general anesthesia.
Conversion to general anesthesia in other than procedure related causes.
during the procedure (intraoperatively)
Secondary Outcomes (3)
propofol dose
during the procedure (intraoperatively)
fentanyl dose
during the procedure (intraoperatively)
sedation score
during the procedure (intraoperatively)
Study Arms (2)
local anesthetic group (control group)
ACTIVE COMPARATOR44 patients will receive local infiltration anesthesia.
ilioinguinal iliohypogastric group
ACTIVE COMPARATOR44patients will receive ilioinguinal iliohypogastric nerve blocks
Interventions
local infiltration by lidocaine in the surgical site
44patients will receive bupivacaine in ilioinguinal \& iliohypogastric nerve blocks
Eligibility Criteria
You may qualify if:
- Patients undergoing TF-TAVI.
- Both sexes.
- Age 18 and above
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ismail Mohammed Ibrahim
Cairo, 11765, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
January 22, 2022
First Posted
February 2, 2022
Study Start
November 11, 2021
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
February 21, 2022
Record last verified: 2022-02