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

Efficacy of Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy: A Randomized Clinical Trial

The investigators hypothesize that erector spinae plane block is better than subcostal transversus abdominis plane block regarding postoperative pain management.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain Management
• Intervention / Treatment: Procedure: Subcostal Transversus Abdominis Plane block; Procedure: Erector Spinae Plane block

Detailed Description

Aim of the work:

The purpose of this study is to compare erector spinae plane block to subcostal transversus abdominis 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 (Hosgood et al., Transplantation 2012; 94: 520-525) 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 0.05, 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.

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 v28 software package (IBM Corp., Armonk, NY, USA).

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Medicine, Cairo University, Cairo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subcostal TAP Block; Group A, The patient was in the supine position then; the Subcostal TAP block was given by a high frequency linear ultrasound transducer (Siemens acuson x300 3-5MHz ultrasound). After skin preparation and isolation, the transducer was placed 2 cm sub-xiphoid, then moved along the subcostal edge to identify the rectus abdominis muscle and the transversus abdominis then, a blunted tip, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) was introduced in-plane 2-3 cm lateral to the transducer, under direct ultrasound visualization. After confirming the correct placement of the needle and the negative aspiration probe, the rest of the anaesthetic substance was injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine on each side after aspiration to avoid intravascular placement, and the dissection of the plane was observed. The block was performed bilaterally.	Procedure: Subcostal Transversus Abdominis Plane block; Group A, The patient was in the supine position then; the Subcostal TAP block was given by a high frequency linear ultrasound transducer (Siemens acuson x300 3-5MHz ultrasound). After skin preparation and isolation, the transducer was placed 2 cm sub-xiphoid, then moved along the subcostal edge to identify the rectus abdominis muscle and the transversus abdominis then, a blunted tip, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) was introduced in-plane 2-3 cm lateral to the transducer, under direct ultrasound visualization. After confirming the correct placement of the needle and the negative aspiration probe, the rest of the anaesthetic substance was injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine on each side after aspiration to avoid intravascular placement, and the dissection of the plane was observed. The block was performed bilaterally.
Active Comparator: ESP Block; Group B, the patient was placed in the prone position. Then, the Erector Spinae block was given by same ultrasound transducer . It was sagittaly placed against the target vertebral level (T7 transverse process) in the prone position and moved in approximately 3-cm lateral to the spinous process.. The Erector Spinae muscle and transverse process was identified, and a same blunted tip , 20-gauge, short bevel needle was advanced, using the in-plane approach, in cephalad-to-caudal direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane. The block was performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the thoracic vertebrae laterally (specifically at T7).	Procedure: Erector Spinae Plane block; Group B, the patient was placed in the prone position. Then, the Erector Spinae block was given by same ultrasound transducer . It was sagittaly placed against the target vertebral level (T7 transverse process) in the prone position and moved in approximately 3-cm lateral to the spinous process.. The Erector Spinae muscle and transverse process was identified, and a same blunted tip , 20-gauge, short bevel needle was advanced, using the in-plane approach, in cephalad-to-caudal direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane. The block was performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the thoracic vertebrae laterally (specifically at T7).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative morphine consumption at 6 hours postoperatively (co-primary endpoint)	Total cumulative morphine consumption (in milligrams) measured at 6 hours postoperatively. Co-primary endpoint with 24-hour cumulative morphine consumption.	From end of surgery to 6 hours postoperatively
Cumulative morphine consumption at 24 hours postoperatively (co-primary endpoint)	Total cumulative morphine consumption (in milligrams) measured at 24 hours postoperatively. Co-primary endpoint with 6-hour cumulative morphine consumption.	From end of surgery to 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure rate in both groups	Failure rate in both groups	in first hour postoperatively
Time taken to perform a successful block	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 to ambulate in both groups	Time to ambulate in both groups	Immediate 24 hours post-operative
p/f ratio postoperatively in both groups	p/f ratio postoperatively in both groups	after first 12, 24 hours postoperatively
Incidence of postoperative pulmonary complication	Incidence of postoperative pulmonary complication	chest x-ray Immediate 24 hours post-operative
Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block	Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block	Immediate 24 hours post-operative
Time for first rescue analgesia in each block	Time for first rescue analgesia in each block	Immediate 24 hours post-operative
Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting	Immediately post operative for 24 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohamed A Ollaek, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: MS-95-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No