The Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block in Laparoscopic Nephrectomy

Not Applicable

Completed

• Conditions: Post Operative Pain Management

• Registration Number: NCT06670508
• Lead Sponsor: Cairo University

Brief Summary

The investigators hypothesis that erector spinae block better than transversus abdominus plane block regarding the post operative pain management.

Detailed Description

Aim of the work:

The purpose of this study to compare erector spinae block to transversus abdominus plane block in laparoscopic nephrectomy regarding analgesic efficacy and postoperative morphine consumption.

Statistical Analysis

I. Sample size:

Sample size was calculated using G-power software. A previous study (reference) reported that the amount of morphine used in the first 6 hours in patients received TAP block in nephrectomy was 12.4 ± 8.4. Assuming that the amount will change by 50% at least with the other block, a power of 80% and an alpha error of 0.5, the minimum sample size required will be 60 patients (30 in each group). We will increase it to 35 in each group to compensate for drop-outs. (15)

II. Statistical analysis:

All measurement indexes will be expressed as mean ± SD/standard error of the mean or number (%). After analysis of normality of data distribution, normally distributed data will be compared by the independent sample t-test. Unpaired quantitative variables will be evaluated by the Student t-test and analysis of variance. The Mann-Whitney U test will be employed for intergroup comparison, and the Wilcoxon signed-rank test for comparison between different time points within the same group. Intergroup comparison of categorical variables will be performed by the chi-square test. Values of A P value less than 0.05 will be considered statistically significant. All data will be statistically analyzed by statisticians using the SPSS 16.0 software package (IBM Corp., Armonk, NY, USA).

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-05-15
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-31
• Status Verified: 2024-11
• Study First Posted: 2024-11-01
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patient age (>18 and <60)
• Both sexes
• American Society of Anesthesiologists (ASA) physical status classes I and II
• Patients scheduled for laparoscopic nephrectomy surgery.

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Exclusion Criteria

• Refusal of regional block
• Patients with uncontrolled diabetes or hypertension
• 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.
• Patients who are allergic to amide local anesthetics.
• Cases converted to open surgery will also be excluded from the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The amount of morphine consumed within 6 hours postoperatively	Immediatly post operative for 6 hours	The amount of morphine consumed within 6 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting	Immediatly post operative for 24 hours	Incidence of postoperative nausea and vomiting
Time to ambulate in both groups	Immediate 24 hours post-operative	Time to ambulate in both groups
Failure rate in both groups	in first hour postoperatively	Failure rate in both groups
Time taken to perform a successful block	30 minutes from time just after local anesthetic injection to successful site of incisions and dermatomal coverage	Time taken to perform a successful block
p/f ratio postoperatively in both groups	after first 12, 24 hours postoperatively	p/f ratio postoperatively in both groups
Incidence of postoperative pulmonary complication	chest x-ray Immediate 24 hours post-operative	Incidence of postoperative pulmonary complication
Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block	Immediate 24 hours post-operative	Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block
Time for first rescue analgesia in each block	Immediate 24 hours post-operative	Time for first rescue analgesia in each block
Total opioid consumption in each block	Immediate 24 hours post-operative	Total opioid consumption in each block

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University, Cairo; 🇪🇬 Cairo, Egypt