Ultrasound-guided Ipsilateral Transverse Abdominis Plane and Ilioinguinal Iliohypogastric Nerve Block.

Not Applicable

Completed

• Conditions: Liver Cirrhosis
• Interventions: Device: Us guided nerve blocks

• Registration Number: NCT04553328
• Lead Sponsor: Ain Shams University

Brief Summary

The purpose of this study is to compare the efficacy of using TAB and ILIH nerve blocks versus ILIH nerve block only for inguinal hernia repair in patients with liver cirrhosis.

Detailed Description

After obtaining institutional ethical committee approval and written informed consent in 2019, 60 patients between the age of 40 and 70 year were divided randomly using a computer generated randomization table and opaque sealed envelopes into two groups (30 patients in each group) according to the type of block they received: Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block. Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only.

Standard monitoring was used throughout the surgery; heart rate (HR), non-invasive mean arterial blood pressure (MAP), respiratory rate (RR) and oxygen saturation (SpO2)documented at baseline before the block then at 5-min intervals intraoperative , then during the immediate postoperative period at 15 and 30 min, and at discharge from the PACU.

A nasal prong was applied and supplemental oxygen at 3 l/min of fresh gas flow was given throughout the procedure. It was explained clearly to the patients that any pain, discomfort, or anxiety would be managed by the administration of local anesthetic (LA) infiltration with bupivacaine 0.25% during the operation or by conversion to general anesthesia (GA) if needed.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-04-20
• Study Completion: 2020-06-02
• Study First Submitted: 2020-08-14
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-17
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status classification groups II and III,undergoing unilateral inguinal hernia repair.
• All patients have liver cirrhosis having a Child-Pugh classification of liver disease (3) class B with a score ≤ 8/15,
• Moemen modified classification of liver disease (4) class B,
• an international normalized ratio (INR)≤1.5.

Exclusion Criteria

• Patients with Child-Pugh ≥ 8/15,
• INR≥ 1.5,
• Grade 3 ascites,
• Serum sodium ≤120 meq/l,
• Recurrent hernia, or bilateral hernia,
• Body mass index (BMI) ≥ to 40 kg/m 2,
• known allergy to any of the medicines used
• Any renal or cardiovascular dysfunction, bronchial asthma, hematological disorders (other than secondary to chronic liver disease),
• Patient refusal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T	Us guided nerve blocks	Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block
Group I	Us guided nerve blocks	Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only.

Primary Outcome Measures

Name	Time	Method
local anesthetic infiltration and convesion to general anesthesia	data will be reported and assessed within 24 weeks.	need for additional local anesthetic infiltration and conversion to general anesesthesia by assessing sensory block adequacy with thermal sensation using an alcohol swab.

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Abbasia, Egypt