PECS II vs. MTP for Analgesia After MRM

NCT ID: NCT06187909

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-08-01

Brief Summary

This randomized controlled study aims to compare the analgesic efficacy of the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block in female patients undergoing modified radical mastectomy (MRM). Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS) over the first 24 hours, with additional evaluation of opioid consumption and complications.

Detailed Description

Modified radical mastectomy (MRM) is associated with significant postoperative pain, which may increase opioid use, delay recovery, and contribute to chronic post-mastectomy pain syndrome. This study compares two regional analgesic techniques: the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block.

The PECS II block involves the injection of local anesthetic between the pectoralis minor and serratus anterior muscles, targeting the pectoral nerves and lateral cutaneous branches of intercostal nerves (T2-T6). It is widely used for anterior chest wall analgesia after breast surgery. The MTP block, a more recent paravertebral-domain technique, deposits anesthetic midway between the transverse process and the pleura, allowing spread to dorsal and ventral rami via the superior costotransverse ligament and potentially achieving broader thoracic segment coverage.

This randomized trial evaluates postoperative pain control using the Visual Analog Scale (VAS) over 24 hours, along with opioid consumption and adverse events. The aim is to determine whether the MTP block offers superior analgesia and an opioid-sparing effect compared to the PECS II block.

Conditions

Breast Neoplasm Female; Postoperative Pain Management

Study Design

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

Study Groups

PECS II block group

Forty-four female patients (ASA I-II, 40-65 years) scheduled for modified radical mastectomy received an ultrasound-guided PECS II block with 20 mL of 0.25% bupivacaine (10 mL between pectoralis major and minor; 10 mL between pectoralis minor and serratus anterior).

Group Type: ACTIVE_COMPARATOR

PECS II BLOCK

Intervention Type: PROCEDURE

In the supine position, as described by Blanco et al., the ultrasound probe was placed transversely beneath the clavicle. After identifying the intermuscular plane between the pectoralis major and minor, 10 mL of 0.25% bupivacaine was injected. The probe was then repositioned laterally to identify the plane between the pectoralis minor and serratus anterior at the third to fourth ribs, where a further 10 mL of 0.25% bupivacaine was injected.

MTP block group

Forty-four female patients (ASA I-II, 40-65 years) scheduled for modified radical mastectomy received an ultrasound-guided midpoint transverse process to pleura (MTP) block with 20 mL of 0.25% bupivacaine (10 mL injected at T2 and 10 mL at T6).

Group Type: ACTIVE_COMPARATOR

MTP BLOCK

Intervention Type: PROCEDURE

The block was performed with the patient in a seated position. The ultrasound probe was positioned parasagittally, approximately 3 cm lateral to the midline, at the T2 and T6 vertebral levels. A 22-gauge needle was advanced in-plane to the midpoint between the transverse process and pleura, and 10 mL of 0.25% bupivacaine was injected at each level. This protocol was adapted from the original technique described by Bhoi et al., with modifications in injection levels and volume.

Interventions

PECS II BLOCK

In the supine position, as described by Blanco et al., the ultrasound probe was placed transversely beneath the clavicle. After identifying the intermuscular plane between the pectoralis major and minor, 10 mL of 0.25% bupivacaine was injected. The probe was then repositioned laterally to identify the plane between the pectoralis minor and serratus anterior at the third to fourth ribs, where a further 10 mL of 0.25% bupivacaine was injected.

Intervention Type: PROCEDURE

MTP BLOCK

The block was performed with the patient in a seated position. The ultrasound probe was positioned parasagittally, approximately 3 cm lateral to the midline, at the T2 and T6 vertebral levels. A 22-gauge needle was advanced in-plane to the midpoint between the transverse process and pleura, and 10 mL of 0.25% bupivacaine was injected at each level. This protocol was adapted from the original technique described by Bhoi et al., with modifications in injection levels and volume.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Female patients scheduled for modified radical mastectomy (MRM).

2. Age between 40 and 65 years.

3. American Society of Anesthesiologists (ASA) physical status I-II.

Exclusion Criteria

1. Known allergy to local anesthetics.

2. Coagulopathy.

3. Infection at the site of injection.

4. Patient refusal.

5. Inability to understand or use the pain scale.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed abdelghany Khalifa ragab

lecturer of Anesthesia, intensive care and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed A. Khalifa, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FMASU MD311/2023

Identifier Type: -

Identifier Source: org_study_id