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

A

Ain Shams University

Status

Completed

Conditions

Liver Cirrhosis

Treatments

Device: Us guided nerve blocks

Study type

Interventional

Funder types

Other

Identifiers

NCT04553328
FMASU R 48/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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