Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation

Phase 4

• Conditions: Anesthesia
• Interventions: Drug: Lidocaine; Drug: Bupivacain

• Registration Number: NCT05220813
• Lead Sponsor: Ain Shams University

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 available

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2022-01-22
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-21
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
local anesthetic group (control group)	Lidocaine	44 patients will receive local infiltration anesthesia.
ilioinguinal iliohypogastric group	Bupivacain	44patients will receive ilioinguinal iliohypogastric nerve blocks

Primary Outcome Measures

Name	Time	Method
conversion to general anesthesia.	during the procedure (intraoperatively)	Conversion to general anesthesia in other than procedure related causes.

Secondary Outcome Measures

Name	Time	Method
fentanyl dose	during the procedure (intraoperatively)	total dose of fentanyl 1-2 microgram / kg
propofol dose	during the procedure (intraoperatively)	Total dose of propofol per hour (0.025-0.075 mg /kg/min)
sedation score	during the procedure (intraoperatively)	sedation score intraoperatively

Trial Locations

Locations (1)

Ismail Mohammed Ibrahim; 🇪🇬 Cairo, Egypt