Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05656872
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2022-11-30
Brief Title:
Transverse Abdominis Plane Block Versus Ilioinguinal-iliohypogastric Block For Analgesia Following Hysterectomy
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1058 235 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 size38 patients 19 patients per group at least were estimated to have a study power of 80 and an alpha error of 005 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 datas 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 005 will be considered statistically significant
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 1058 235 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 size38 patients 19 patients per group at least were estimated to have a study power of 80 and an alpha error of 005 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 datas 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 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None