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Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05220813
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
5.6
Anticipated Duration (Months)
15.7
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Does Ilioinguinal Block Provide Satisfactory Analgesia During Transcatheter Aortic Valve Implantation Procedure? A Comparative Study
Actual Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. conversion to general anesthesia. [during the procedure (intraoperatively)]

    Conversion to general anesthesia in other than procedure related causes.

Secondary Outcome Measures

  1. propofol dose [during the procedure (intraoperatively)]

    Total dose of propofol per hour (0.025-0.075 mg /kg/min)

  2. fentanyl dose [during the procedure (intraoperatively)]

    total dose of fentanyl 1-2 microgram / kg

  3. sedation score [during the procedure (intraoperatively)]

    sedation score intraoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ismail Mohammed Ibrahim Cairo Egypt 11765

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ismail Mohammed, principal investigator, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05220813
Other Study ID Numbers:
  • FMASU R 187/2021
First Posted:
Feb 2, 2022
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lidocaine
Bupivacaine

Study Results

No Results Posted as of Feb 21, 2022