Clinical trial NCT05656872: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Time to first rescue analgesia request
timeFrame: Immediatly post operative for 24 hours
Secondary outcomes:
measure: Total nalbuphine consumption in each block (mg)
timeFrame: Immediate 24 hours post-operative
measure: VAS score
timeFrame: 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.
measure: Intraoperative hemodynamics
timeFrame: 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
measure: Incidence of postoperative nausea and vomiting
timeFrame: Immediate 24 hours post-operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
city: Cairo
country: Egypt
facility: Mohamed Ollaek
Study officials:
affiliation: Department of Anesthesia, Surgical ICU and Pain Management
name: Mohamed A Ollaek, MD
role: PRINCIPAL_INVESTIGATOR
References: