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Transverse Abdominis Plane Block Versus Ilioinguinal-iliohypogastric Block For Analgesia Following Hysterectomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transverse Abdominis Plane Block
Ilioinguinal-iliohypogastric block
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants will be adult patients (18-65 years) ASA I-II Scheduled for elective open TAH Exclusion Criteria: Patient refusal Any known allergy to local anesthetic Patients with neurological, psychological disorders or those lacking cooperation Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion. Patients with bleeding disorders defined as (INR >2) and/ or (platelet count <100,000/µL) Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement

Sites / Locations

  • Faculty of Medicine, Cairo University
  • Mohamed Ollaek

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TAP Block

IIIH Block

Arm Description

Transversus abdominus plane (TAP) block will be used as postoperative analgesia

Ilioinguinal-iliohypogastric (IIIH) block will be used as postoperative analgesia

Outcomes

Primary Outcome Measures

Time to first rescue analgesia request
Time to first rescue analgesia request

Secondary Outcome Measures

Total nalbuphine consumption in each block (mg)
Total nalbuphine consumption in each block (mg)
VAS score
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 centimeters line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Intraoperative hemodynamics
Heart Rate (HR) beats/min. Mean Arterial Blood Pressure (mg)
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting

Full Information

First Posted
November 30, 2022
Last Updated
May 11, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05656872
Brief Title
Transverse Abdominis Plane Block Versus Ilioinguinal-iliohypogastric Block For Analgesia Following Hysterectomy
Official Title
A Comparative Study Between Transverse Abdominis Plane Block Versus Ilioinguinal-iliohypogastric Block For Postoperative Analgesia Following Open Abdominal Hysterectomy : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The investigators hypothesis that ilioinguinal iliohypogastric nerves block could provide a potent modality of postoperative pain control as compared to Transverse Abdominis Plane block in open abdominal hysterectomy
Detailed Description
Aim of the work the aim of the study is to compare between the analgesic effect of Transverse Abdominis Plane Block and Ilioinguinal-iliohypogastric block following open abdominal hysterectomy Objectives to compare between the analgesic effect of Transverse Abdominis Plane Block and Ilioinguinal-iliohypogastric block For Postoperative Analgesia following open abdominal hysterectomy to measure the incidence of complications following both blocks as hematoma, block failure, infection at injection site Sample size: Our primary outcome is the time to first rescue analgesia request. In a previous study, the meantime to first rescue analgesia was 10.58 ± 2.35 hours (6). The investigators calculated a sample size that could detect a mean difference of 20% between both study groups. MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium) was used to calculate the sample size.38 patients( 19 patients per group) at least were estimated to have a study power of 80% and an alpha error of 0.05. This number will be increased to 42 patients (21 patients per group) to compensate for possible dropouts. Sample size calculation was performed guided by the power of 80%, confidence level of 95%. Statistical analysis: For data analysis, the Statistical Package for Social Science (SPSS) software, version 26 for Microsoft Windows (SPSS Inc., Chicago, IL, USA) will be used. The Chi-squared test will be used to examine categorical data, which will be given as frequency (percent). The Shapiro-Wilk test will be used to verify for normality in continuous data, and the results will be provided as mean (standard deviation) or median (interquartile range) as appropriate. Depending on the data's normality, the unpaired t-test or the Mann Whitney test will be used to assess it. Repeated measures will be examined using analysis of variance (ANOVA), with posthoc pairwise comparisons using the Bonferroni tests. A P value less than 0.05 will be considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Block
Arm Type
Active Comparator
Arm Description
Transversus abdominus plane (TAP) block will be used as postoperative analgesia
Arm Title
IIIH Block
Arm Type
Active Comparator
Arm Description
Ilioinguinal-iliohypogastric (IIIH) block will be used as postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Transverse Abdominis Plane Block
Intervention Description
Group T, will be performed in a supine position after skin sterilization, a linear high-frequency transducer Siemens acuson x300 3-5 MHZ will be placed in the transverse plane to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest. The abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) will be visualized. A blunt tip,20-gauge, short bevel needle(Pajunk Sonoplex, Germany) will be inserted in-plane and advanced anterior to posterior under continuous visualization until the tip reaches between the internal oblique and the transversus abdominis muscle. After negative aspiration, 20 mL of bupivacaine 0.25%, lidocaine 1% will be injected. Separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in-between will be observed. The procedure will be repeated following the same steps on the other side.
Intervention Type
Procedure
Intervention Name(s)
Ilioinguinal-iliohypogastric block
Intervention Description
Group I, will receive an Ultrasound-guided IIIH block that will be performed in a supine position after skin sterilization, a linear high-frequency transducer Siemens acuson x300 3-5 MHZ will be placed on the line between the anterior superior iliac spine and the umbilicus, where 3 layers of muscles (extra-abdominal oblique, intra-abdominal oblique, and transverse abdominis) will be visible on the inner side of the anterior superior iliac spine.A blunt tip,20-gauge, short bevel needle(Pajunk Sonoplex, Germany) will be inserted in-plane and advanced anterior to posterior under continuous visualization until the tip reaches between the internal oblique and the transversus abdominis muscle next to the iliohypogastric/ilioinguinal nerve. After negative aspiration, 20 mL of bupivacaine 0.25%, lidocaine 1% will be injected. The procedure will be repeated following the same steps on the other side.
Primary Outcome Measure Information:
Title
Time to first rescue analgesia request
Description
Time to first rescue analgesia request
Time Frame
Immediatly post operative for 24 hours
Secondary Outcome Measure Information:
Title
Total nalbuphine consumption in each block (mg)
Description
Total nalbuphine consumption in each block (mg)
Time Frame
Immediate 24 hours post-operative
Title
VAS score
Description
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 centimeters line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time Frame
Immediate post-operative period every 5 minutes for the first 30 minutes , 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours.
Title
Intraoperative hemodynamics
Description
Heart Rate (HR) beats/min. Mean Arterial Blood Pressure (mg)
Time Frame
At baseline, 5 minutes after intubation, every 10 minutes till the end of the surgery, immediately after extubation, 5 minutes after extubation, and every 10 minutes in PACU for 30 minutes till the discharge of the patient
Title
Incidence of postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting
Time Frame
Immediate 24 hours post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will be adult patients (18-65 years) ASA I-II Scheduled for elective open TAH Exclusion Criteria: Patient refusal Any known allergy to local anesthetic Patients with neurological, psychological disorders or those lacking cooperation Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion. Patients with bleeding disorders defined as (INR >2) and/ or (platelet count <100,000/µL) Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Ollaek, MD
Organizational Affiliation
Department of Anesthesia, Surgical ICU and Pain Management
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Cairo University
City
Cairo
Country
Egypt
Facility Name
Mohamed Ollaek
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Transverse Abdominis Plane Block Versus Ilioinguinal-iliohypogastric Block For Analgesia Following Hysterectomy

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