Comparative Study Between Combined Modified Pectoral Nerve Block (PECSΙΙ) and Transversus Thoracic Plane Block Versus Erector Spinae Plane Block for Post-operative Analgesia Following Breast Surgeries, (randomized Clinical Trial Study)

NCT06783764 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: FMASU MS560/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the analgesic effect and safety of Modified Pectoral Nerve Block and Transverse thoracic plane block versus Erector Supine plane Block in cases undergoing modified radical mastectomy (MRM).

Conditions

Post Operative Analgesia; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• The Nalbuphine consumption

  The Nalbuphine consumption in the first 24 hours post-operative.

  The first 24 hours post-operative.

Secondary Outcomes (1)

• severity of pain post operative

  The first 24 hours post-operative.

Study Arms (2)

PECS II block and TTPB group

ACTIVE COMPARATOR

will receive a combination of PECS II block and TTPB (injection of 10 ml 0.25% bupivacaine between pectoralis major and minor muscles and 10 ml between the pectoralis minor and serratus anterior muscles) at the third or the fourth rib, then 10 ml between the internal inter-costal muscles and the transversus thoracic muscle

Procedure: PECS II block and transverse thoracic plane block; Drug: bupivacaine 0.25 % injection

ESPB group

ACTIVE COMPARATOR

: ESPB (30 ml of 0.25% bupivacaine injected deep to the erector spinae muscle at the transverse process of the fifth thoracic vertebrae)

Procedure: Erector Spinae Plane Block; Drug: bupivacaine 0.25 % injection

Interventions

PECS II block and transverse thoracic plane block PROCEDURE

will receive a combination of PECS II block and TTPB (injection of 10 ml 0.25% bupivacaine between pectoralis major and minor muscles and 10 ml between the pectoralis minor and serratus anterior muscles) at the third or the fourth rib, then 10 ml between the internal inter-costal muscles and the transversus thoracic muscle

PECS II block and TTPB group

Erector Spinae Plane Block PROCEDURE

ESPB (30 ml of 0.25% bupivacaine injected deep to the erector spinae muscle at the transverse process of the fifth thoracic vertebrae)

ESPB group

bupivacaine 0.25 % injection DRUG

injection of 10 ml 0.25% bupivacaine between pectoralis major and minor muscles and 10 ml between the pectoralis minor and serratus anterior muscles) at the third or the fourth rib, then 10 ml between the internal inter-costal muscles and the transversus thoracic muscle

PECS II block and TTPB group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: Adult female patients ,aged 25-65 years undergoing modified radical mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25-65 years.
• BMI 18-35.
• American Society of Anesthesiologists(ASA) Physical Status Class-I, II and III Scheduled for breast surgery

You may not qualify if:

• \- Refusal to give written informed consent.
• History of allergy to the medications used in the study.
• Contraindications to regional anesthesia (including coagulopathy -INR\>1.6, PLT\<50 × 10\^3/cmm- and local infection).
• Psychiatric disorder that leading to inability to cooperate, speak or read.
• BMI more than 35.
• Patients on medications for chronic pain.
• Previous anterior chest wall surgery.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Injections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: May 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 5, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

EG (1)