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Completed

NCT Number: NCT06670508

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

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

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Key information

Conditions

Post Operative Pain Management

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Cairo University, Cairo

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subcostal Transversus Abdominis Plane Block

Procedure

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.

Erector Spinae Plane Block

Procedure

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).

Primary outcomes

  1. Cumulative morphine consumption at 6 hours postoperatively (co-primary endpoint)

    Time frame: From end of surgery to 6 hours postoperatively

    Total cumulative morphine consumption (in milligrams) measured at 6 hours postoperatively. Co-primary endpoint with 24-hour cumulative morphine consumption.

  2. Cumulative morphine consumption at 24 hours postoperatively (co-primary endpoint)

    Time frame: From end of surgery to 24 hours postoperatively

    Total cumulative morphine consumption (in milligrams) measured at 24 hours postoperatively. Co-primary endpoint with 6-hour cumulative morphine consumption.

Secondary outcomes

  1. Failure rate in both groups

    Time frame: in first hour postoperatively

    Failure rate in both groups

  2. Time taken to perform a successful block

    Time frame: 30 minutes from time just after local anesthetic injection to successful site of incisions and dermatomal coverage

    Time taken to perform a successful block

  3. Postoperative nausea and vomiting

    Time frame: Immediately post operative for 24 hours

    Incidence of postoperative nausea and vomiting

  4. Time to ambulate in both groups

    Time frame: Immediate 24 hours post-operative

    Time to ambulate in both groups

  5. p/f ratio postoperatively in both groups

    Time frame: after first 12, 24 hours postoperatively

    p/f ratio postoperatively in both groups

  6. Incidence of postoperative pulmonary complication

    Time frame: chest x-ray Immediate 24 hours post-operative

    Incidence of postoperative pulmonary complication

  7. Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block

    Time frame: Immediate 24 hours post-operative

    Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block

  8. Time for first rescue analgesia in each block

    Time frame: Immediate 24 hours post-operative

    Time for first rescue analgesia in each block

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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