Transverse Abdominis Plane Block Versus Ilioinguinal-iliohypogastric Block For Analgesia Following Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): Transverse Abdominis Plane Block; Ilioinguinal-iliohypogastric block
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care