Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation

Ain Shams University

Status and phase: Unknown; Phase 4

Conditions: Anesthesia

Treatments: Drug: Bupivacain; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05220813

FMASU R 187/2021

Details and patient eligibility

About

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).

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups

local anesthetic group (control group)

Active Comparator group

Description:

44 patients will receive local infiltration anesthesia.

Treatment:

Drug: Lidocaine

ilioinguinal iliohypogastric group

Active Comparator group

Description:

44patients will receive ilioinguinal iliohypogastric nerve blocks

Treatment:

Drug: Bupivacain