Transverse Abdominis Plane Block Versus Ilioinguinal-iliohypogastric Block

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05656872
Study type	Interventional
Source	Cairo University
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2022
Completion date	April 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms