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

NCT06670508 | Completed

• 1 other identifier: MS-95-2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain Management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Failure rate in both groups

  in first hour postoperatively

• Time taken to perform a successful block

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

• Postoperative nausea and vomiting

  Immediately post operative for 24 hours

• Time to ambulate in both groups

  Immediate 24 hours post-operative

• p/f ratio postoperatively in both groups

  after first 12, 24 hours postoperatively

Study Arms (2)

Subcostal TAP Block

ACTIVE COMPARATOR

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

ESP Block

ACTIVE COMPARATOR

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

Interventions

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).

ESP Block

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.

Subcostal TAP Block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University, Cairo

Cairo, Egypt

Location

Study Officials

• Mohamed A Ollaek, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 1, 2024
• Study Start: October 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 15, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

EG (1)