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Clinical Trials/NCT05220813
NCT05220813
Unknown
Phase 4

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

Ain Shams University1 site in 1 country88 target enrollmentNovember 11, 2021

Overview

Phase
Phase 4
Intervention
Lidocaine
Conditions
Anesthesia
Sponsor
Ain Shams University
Enrollment
88
Locations
1
Primary Endpoint
conversion to general anesthesia.
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 11, 2021
End Date
May 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ismail Mohammed

principal investigator

Ain Shams University

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.

Arms & Interventions

local anesthetic group (control group)

44 patients will receive local infiltration anesthesia.

Intervention: Lidocaine

ilioinguinal iliohypogastric group

44patients will receive ilioinguinal iliohypogastric nerve blocks

Intervention: Bupivacain

Outcomes

Primary Outcomes

conversion to general anesthesia.

Time Frame: during the procedure (intraoperatively)

Conversion to general anesthesia in other than procedure related causes.

Secondary Outcomes

  • fentanyl dose(during the procedure (intraoperatively))
  • propofol dose(during the procedure (intraoperatively))
  • sedation score(during the procedure (intraoperatively))

Study Sites (1)

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