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

NCT04553328 | Completed DMC

• 1 other identifier: FMASU R 48/2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

Transverse aabdominis plane

Outcome Measures

Primary Outcomes (1)

• local anesthetic infiltration and convesion to general anesthesia

  need for additional local anesthetic infiltration and conversion to general anesesthesia by assessing sensory block adequacy with thermal sensation using an alcohol swab.

  data will be reported and assessed within 24 weeks.

Study Arms (2)

Group T

ACTIVE COMPARATOR

Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block

Device: Us guided nerve blocks

Group I

ACTIVE COMPARATOR

Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only.

Device: Us guided nerve blocks

Interventions

Us guided nerve blocks DEVICE

The ILIH nerves were identified and located in the fascia compartment between the internal oblique and the transverse abdominis or external oblique muscles, a 20 G needle was advanced between the aponeurosis of the internal oblique and transverses abdominis muscles then 30 ml bupivacaine 0.25% was injected with intermittent aspiration,then 10 ml bupivacaine 0.25% was injected around the nerves.

Also known as: drug used is bupivacaine

Group I; Group T

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasia, 11566, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dina Badre, PHD

  Associate professor of Anesthesia and ICU, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The patients were divided randomly 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.

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: September 17, 2020
• Study Start: September 1, 2019
• Primary Completion: April 20, 2020
• Study Completion: June 2, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: within 1 month , for 3 years
• Access Criteria: anesthesia doctors in same field

Locations

EG (1)