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

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Us guided nerve blocks
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Liver Cirrhosis focused on measuring Transverse aabdominis plane

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ain Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group T

Group I

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2020
Last Updated
September 15, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04553328
Brief Title
Ultrasound-guided Ipsilateral Transverse Abdominis Plane and Ilioinguinal Iliohypogastric Nerve Block.
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
June 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Transverse aabdominis plane

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group T
Arm Type
Active Comparator
Arm Description
Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block
Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only.
Intervention Type
Device
Intervention Name(s)
Us guided nerve blocks
Other Intervention Name(s)
drug used is bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
local anesthetic infiltration and convesion to general anesthesia
Description
need for additional local anesthetic infiltration and conversion to general anesesthesia by assessing sensory block adequacy with thermal sensation using an alcohol swab.
Time Frame
data will be reported and assessed within 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Badre, PHD
Organizational Affiliation
Associate professor of Anesthesia and ICU, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Final results are to be shared with other researchers after approval of publication
IPD Sharing Time Frame
within 1 month , for 3 years
IPD Sharing Access Criteria
anesthesia doctors in same field

Learn more about this trial

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

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