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

NCT ID: NCT05656872

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-04-30

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

TAP Block

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

Group Type: ACTIVE_COMPARATOR

Transverse Abdominis Plane Block

Intervention Type: PROCEDURE

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.

IIIH Block

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

Group Type: ACTIVE_COMPARATOR

Ilioinguinal-iliohypogastric block

Intervention Type: PROCEDURE

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.

Interventions

Transverse Abdominis Plane Block

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

Ilioinguinal-iliohypogastric block

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Mohamed Youssef Ollaek

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A Ollaek, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Surgical ICU and Pain Management

Locations

Faculty of Medicine, Cairo University

Cairo, , Egypt

Mohamed Ollaek

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-617-2021

Identifier Type: -

Identifier Source: org_study_id