Compare Analgesia Between MTP Block And ESPB in MRM

NCT06888258 | Recruiting DMC

• 1 other identifier: AP2407-201-014
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to compare the analgesic efficacy between ultrasound guided Erector Spinae Plane block Vs midpoint transverse process to Pleura block in modified radical mastectomy surgeries

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• post-operative opioid (morphine) consumption in the 1st 24 hours

  Total post operative morphine dosage in mg required

  24 hours

Secondary Outcomes (7)

• Time to first rescue analgesia, starting after extubation. In minutes

  24 hours

• Total dose of fentanyl required intraoperative (including induction dose) in microgram

  24 hours

• Numerical pain rating score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery. Score from 0 to 10 where 10 is the worst pain

  24 hours

• Change in heart rate (rate per minute) intraoperatively at 30 minutes interval in comparison to baseline reading.

  24 hours

• Change mean arterial blood pressure (mmHg) intraoperatively at 30 minutes interval in comparison to baseline reading.

  24 hours

Study Arms (3)

Erector Spinae Plane block arm

ACTIVE COMPARATOR

Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process. Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.

Procedure: Ultrasound guided Erector Spinae Plane block

Mid-point Transverse Process to Pleura block arm

ACTIVE COMPARATOR

Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.

Procedure: Ultrasound guided Mid-point to Pleura block

Control arm

NO INTERVENTION

Patients in this arm will not receive block but they will receive Intravenous morphine

Interventions

Ultrasound guided Erector Spinae Plane block PROCEDURE

Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process. Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.

Erector Spinae Plane block arm

Ultrasound guided Mid-point to Pleura block PROCEDURE

Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.

Mid-point Transverse Process to Pleura block arm

Eligibility Criteria

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

You may qualify if:

• ASA I-II.
• Undergoing modified radical mastectomy surgery.
• Body mass index (BMI) from 18.5 to 30 kg/m2

You may not qualify if:

• Patient refusal.
• Known allergy to local anesthetics.
• Bleeding disorders; platelets count \<50,000 , prothrombin concentration \< 60% or any coagulopathy disorder.
• Use of any anti-coagulants.
• Inability to provide informed consent.
• ASA III-IV.
• Neurological disorders.
• Patient with psychiatric disorders

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National cancer institute, Cairo University

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maie Kamal El-Din Helaly, MD

  National cancer institute, Cairo University

  STUDY DIRECTOR

Central Study Contacts

mahmoud Saad Mahmoud Mohamed Mohamed, Msc

CONTACT

+201094555375; doc.mahmoudsaad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be randomly assigned into three equal comparable groups using computer-generated random numbers in opaque closed envelopes, each of which will include 30 patients. With allocation ratio 1:1:1 Group M (mid-point transverse process to pleura block MTP) N=3o Patients will receive Ultrasound guided mid-point transverse process to pleura block preoperative with injection of 20 ml bupivacaine 0.25%.Then patients will be transferred to operating room. Group E (Erector Spinae Plane Block ESB) N=3o Patients will receive Ultrasound guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%. Patients will be transferred to operating room. Group C (control group) N=30 Patients will not receive any block. Induction will be performed by using a regimen of IV by fentanyl 1 μg/kg, Additional bolus doses of fentanyl 0.5 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 21, 2025
• Study Start: October 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

EG (1)