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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553328
• Other study ID #: FMASU R 48/2019
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 2, 2020

Study information

• Verified date: September 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Device:
• Us guided nerve blocks
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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.