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

NCT ID: NCT06670508

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-05-15

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).

Conditions

Post Operative Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

TAP Block

Group A, The patient was in the supine position then; the 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.

Group Type: ACTIVE_COMPARATOR

Transversus Abdominis Plane block

Intervention Type: PROCEDURE

Group A, The patient was in the supine position then; the 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.

ES 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 lumbar vertebrae laterally.

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane block

Intervention Type: 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 lumbar vertebrae laterally.

Interventions

Transversus Abdominis Plane block

Group A, The patient was in the supine position then; the 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.

Intervention Type: 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 lumbar vertebrae laterally.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Mohamed Youssef Ollaek

Assisstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A Ollaek, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Medicine, Cairo University, Cairo

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-95-2023

Identifier Type: -

Identifier Source: org_study_id