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Clinical Trials/NCT04553328
NCT04553328
Completed
Not Applicable

Ultrasound-guided Ipsilateral Transverse Abdominis Plane and Ilioinguinal-iliohypogastric Nerve Block Versus Ipsilateral Illioinguinal- Illiohypogastric Nerve Block for Inguinal Hernia Repair in Patients With Liver Cirrhosis

Ain Shams University1 site in 1 country60 target enrollmentSeptember 1, 2019
ConditionsLiver Cirrhosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cirrhosis
Sponsor
Ain Shams University
Enrollment
60
Locations
1
Primary Endpoint
local anesthetic infiltration and convesion to general anesthesia
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
June 2, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dina Salah Eldin Mahmoud Badre

Clinical Professor

Ain Shams University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

local anesthetic infiltration and convesion to general anesthesia

Time Frame: 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.

Study Sites (1)

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