Ultrasound-Guided PEC I vs SAP Block for Postoperative Analgesia in Modified Radical Mastectomy

NCT07388238 | Completed

• 1 other identifier: MS 263/ 2021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized double-blind controlled clinical trial was conducted to compare the analgesic efficacy of ultrasound-guided Pectoral Nerve Block versus Serratus Anterior Plane Block in female patients undergoing Modified Radical Mastectomy. Sixty-four ASA I-II female patients aged 35-60 years were randomly allocated into two equal groups: Group I received PEC I block and Group II received SAPB, using 20 ml of 0.25% bupivacaine in both groups after induction of general anesthesia. Postoperative pain was assessed using the Numeric Rating Scale (NRS) for 24 hours. Hemodynamic parameters, time to first rescue analgesia, total postoperative opioid consumption, and side effects were recorded. The SAPB group showed significantly lower postoperative pain scores during the first 6 hours, significantly longer time to first rescue analgesia, and significantly lower total pethidine consumption compared to the PEC I group. In addition, mean arterial blood pressure and heart rate were significantly lower intraoperatively and during early postoperative periods in the SAPB group. The incidence of postoperative nausea and vomiting was significantly higher in the PEC I group. Conclusion: Ultrasound-guided Serratus Anterior Plane Block provides superior postoperative analgesia with better hemodynamic stability and fewer opioid-related side effects compared to Pectoral Nerve Block in patients undergoing Modified Radical Mastectomy modified radical mastectomy

Conditions

Breast Cancer; Modified Radical Mastectomy; Pectoral Nerve Blocks; Serratus Anterior Plane Block

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity measured by Numeric Rating Score (NRS)

  Pain intensity will be assessed using the 10-point NRS at multiple time points: At the entry to the PACU, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 hours postoperatively. NRS scoring: 0 = no pain, 1-3 = mild pain, 4-6= moderate pain, 7-10 = severe pain. The mean NRS score during the first 24 postoperative hours will serve as the primary outcome to evaluate analgesic efficacy between study groups.

  Within the first 24 hours postoperatively

Secondary Outcomes (5)

• Time to first rescue analgesia

  From the end of surgery to the administration of the first rescue analgesic.

• Total pethidine consumption after surgery

  Within the first 24 hours postoperatively

• Mean arterial blood pressure

  Within the first 24 hours postoperatively

• Heart Rate

  From the skin incision and up to 24 hours postoperatively

• Adverse events

  Within the first 24 hours postoperatively

Study Arms (2)

Ultrasound-Guided Pectoral Nerve Block (PECS I) Arm

EXPERIMENTAL

Participants in this arm receive an ultrasound-guided pectoral nerve block (PECS I) after induction of general anesthesia, using 20 mL of 0.25% bupivacaine injected into the interpectoral plane between the pectoralis major and pectoralis minor muscles for postoperative analgesia following modified radical mastectomy.

Procedure: Ultrasound-Guided Pectoral Nerve Block (PECS I)

Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Arm

EXPERIMENTAL

Participants in this arm receive an ultrasound-guided serratus anterior plane block after induction of general anesthesia, using 20 mL of 0.25% bupivacaine injected between the serratus anterior muscle and the external intercostal muscles for postoperative analgesia following modified radical mastectomy.

Procedure: Ultrasound-Guided Serratus Anterior Plane Block (SAPB)

Interventions

Ultrasound-Guided Pectoral Nerve Block (PECS I) PROCEDURE

Participants receive an ultrasound-guided pectoral nerve block (PECS I) after induction of general anesthesia. A 20 mL solution of 0.25% bupivacaine is injected into the interpectoral plane between the pectoralis major and minor muscles. The block is performed under aseptic conditions using an in-plane needle approach from medial to lateral for postoperative analgesia following modified radical mastectomy.

Ultrasound-Guided Pectoral Nerve Block (PECS I) Arm

Ultrasound-Guided Serratus Anterior Plane Block (SAPB) PROCEDURE

Participants receive an ultrasound-guided serratus anterior plane block after induction of general anesthesia. A 20 mL solution of 0.25% bupivacaine is injected between the serratus anterior muscle and the external intercostal muscles at the midaxillary line under aseptic conditions. The block is performed using an in-plane needle approach from caudal to cranial for postoperative analgesia following modified radical mastectomy.

Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Arm

Eligibility Criteria

• Age: 35 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physical status: ASA grades I and II
• Age between 35 and 60.

You may not qualify if:

• Known Allergy to one of the study drugs.
• Pregnant patients.
• Other Malignancy.
• History or evidence of coagulopathy, use of anti coagulant or anti platelet therapy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Anaethesia Department, Ain Shams University Hospital

Cairo, Cairo Governorate, 11517, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigatir

Model Details: This study follows a randomized parallel-group interventional model comparing two established regional anesthesia techniques: PEC block and SAP block. Participants are randomly allocated in a 1:1 ratio using concealed assignment to ensure unbiased group distribution. Each participant receives only the technique assigned, with no crossover permitted. Standardized protocols are applied for induction, drug dosing, positioning, and monitoring to minimize procedural variability. Outcome assessors and data collectors are blinded to group allocation whenever feasible. Both groups follow identical perioperative timelines, including preoperative evaluation, intraoperative monitoring, and postoperative pain assessment. This model allows a controlled and unbiased comparison of the efficacy, safety, and clinical performance of the two techniques under uniform conditions.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 5, 2026
• Study Start: May 3, 2021
• Primary Completion: November 6, 2021
• Study Completion: December 9, 2021
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon publication of the study results.\*End Date: 5 years after publication.
• Access Criteria: Qualified researchers may request access to de-identified individual participant data (IPD) from this study, including clinical parameters, ventilatory settings, oxygenation indices, and demographic information. Supporting information such as Study Protocol, Statistical Analysis Plan (SAP), and Clinical Study Report (CSR) will also be provided. Requests will be submitted to the Principal Investigator for review. Approved requests will receive the data through a secure repository to ensure confidentiality. Data will not include any personal identifiers, and access is limited to research purposes only.

Locations

EG (1)