Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220813
• Other study ID #: FMASU R 187/2021
• Status: Recruiting
• Phase: Phase 4
• Start date: November 11, 2021
• Est. completion date: May 2022

Study information

• Verified date: February 2022
• Source: Ain Shams University
• Contact: ismail M ibrahim, MD
• Phone: +20224662448
• Email: doc_ismail_2006[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Lidocaine
local infiltration by lidocaine in the surgical site
• Bupivacain
44patients will receive bupivacaine in ilioinguinal & iliohypogastric nerve blocks

Locations

Country	Name	City	State
Egypt	Ismail Mohammed Ibrahim	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	conversion to general anesthesia.	Conversion to general anesthesia in other than procedure related causes.	during the procedure (intraoperatively)
Secondary	propofol dose	Total dose of propofol per hour (0.025-0.075 mg /kg/min)	during the procedure (intraoperatively)
Secondary	fentanyl dose	total dose of fentanyl 1-2 microgram / kg	during the procedure (intraoperatively)
Secondary	sedation score	sedation score intraoperatively	during the procedure (intraoperatively)