PECS II vs. MTP for Analgesia After MRM

NCT06187909 | Completed Results

• 1 other identifier: FMASU MD311/2023
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female; Postoperative Pain Management

Keywords

Anesthesia, Conduction; Mastectomy, Modified Radical; Breast Neoplasms; Postoperative Pain; Analgesia, Opioid; Nerve Block

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain Severity Assessed by VAS at Hour-4

  Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome

  will be evaluated at hour-4 postoperatively

Secondary Outcomes (4)

• Post-operative Pain Severity Assessed by VAS on Admission to Postanesthesia Care Unit (PACU), at Hour-2, Hour-8, Hour-12, Hour-18 and Hour-24.

  24 hours postoperatively

• Time of First Rescue Analgesia

  24 hours postoperatively

• Cumulative Post-operative Nalbuphine Consumption in the First 24 Hours

  24 hours postoperatively

• Incidence of Postoperative Side Effects and Complications

  24 hours postoperatively

Study Arms (2)

PECS II block group

ACTIVE COMPARATOR

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).

Procedure: PECS II BLOCK

MTP block group

ACTIVE COMPARATOR

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).

Procedure: MTP BLOCK

Interventions

PECS II BLOCK 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.

PECS II block group

MTP BLOCK 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.

MTP block group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Study population restricted to female patients undergoing modified radical mastectomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients scheduled for modified radical mastectomy (MRM).
• Age between 40 and 65 years.
• American Society of Anesthesiologists (ASA) physical status I-II.

You may not qualify if:

• Known allergy to local anesthetics.
• Coagulopathy.
• Infection at the site of injection.
• Patient refusal.
• Inability to understand or use the pain scale.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Yasser Mohamed Reyad Ahmed El-Mansoury
• Organization: Department of Anesthesia, Intensive Care, and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt

yassermoahmed0102107@med.asu.edu.eg

01000286206

Study Officials

• Ahmed A. Khalifa, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients were sedated during block placement; however, due to the distinct anatomical sites of the two techniques, full patient blinding could not be ensured. Outcome assessors gathering postoperative data were blinded to group allocation, and the anesthesiologists performing the blocks were not engaged in data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anesthesia, intensive care and pain management

Model Details: This study used a parallel assignment model involving 88 ASA I-II female patients undergoing modified radical mastectomy. Participants were randomized into two equal groups to receive either an ultrasound-guided PECS II block or a midpoint transverse process to pleura (MTP) block, each with 20 mL of 0.25% bupivacaine. Postoperative analgesic efficacy was assessed using the Visual Analog Scale (VAS), time to first rescue analgesia, total nalbuphine consumption, and incidence of complications over 24 hours.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 3, 2024
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 21, 2026
• Results First Posted: August 13, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)