Clinical trial NCT06670508: The Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block in Laparoscopic Nephrectomy
Official title: The Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block in Laparoscopic Nephrectomy: Randomized Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain Management
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

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

Primary outcomes:
measure: The amount of morphine consumed within 6 hours postoperatively
timeFrame: Immediatly post operative for 6 hours
Secondary outcomes:
measure: Failure rate in both groups
timeFrame: in first hour postoperatively
measure: Time taken to perform a successful block
timeFrame: 30 minutes from time just after local anesthetic injection to successful site of incisions and dermatomal coverage
measure: Postoperative nausea and vomiting
timeFrame: Immediatly post operative for 24 hours
measure: Time to ambulate in both groups
timeFrame: Immediate 24 hours post-operative
measure: p/f ratio postoperatively in both groups
timeFrame: after first 12, 24 hours postoperatively
measure: Incidence of postoperative pulmonary complication
timeFrame: chest x-ray Immediate 24 hours post-operative
measure: Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block
timeFrame: Immediate 24 hours post-operative
measure: Time for first rescue analgesia in each block
timeFrame: Immediate 24 hours post-operative
measure: Total opioid consumption in each block
timeFrame: Immediate 24 hours post-operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University, Cairo
Study officials:
affiliation: Cairo University
name: Mohamed A Ollaek, MD
role: PRINCIPAL_INVESTIGATOR
References: