Effectiveness of Ultrasound Guided PECS Block on Opioid Consumption and Patient Satisfaction Through Adequate Pain Control Following Breast Cancer Surgery.

NCT04343807 | Completed DMC

• 1 other identifier: 3543
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common and leading cause of cancer deaths among females worldwide. Patients undergoing modified radical mastectomy (MRM) are associated with moderate to severe acute postoperative pain and shoulder mobility restriction. This study aims to determine the effectiveness of ultrasound-guided PECS block for reducing opioid consumption, providing adequate postoperative pain management and improving patient satisfaction following breast cancer surgery.

Conditions

Breast Neoplasm Female; Pain, Postoperative; Pain; Analgesia; Anaesthesia; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Total intraoperative opioid consumption

  Total intraoperative nalbuphine

  During surgical procedure

• Total postoperative opioid consumption

  Total Rescue Tramadol Consumption

  First 24 hours after surgery

Secondary Outcomes (3)

• Patient Satisfaction

  First 24 hours after surgery

• Postoperative pain score

  1, 6,12 and 24 hours after surgery

• Postoperative nausea and vomiting

  First 24 hours after surgery

Study Arms (2)

PECS block

ACTIVE COMPARATOR

For patients in PECS group (PG), after induction of general anesthesia, the nerve block will be performed using the ultrasound-guided technique described by Blanco and colleagues. Block will be performed with a 22-gauge 100 mm needle (Stimuplex, B. Braun Medical Inc., Pennsylvania, USA) using Mindray M7 imaging system (Diagnostic Instruments Inc., China) with a high-frequency (6-13 MHz) linear array transducer.20 mL of ropivacaine 0.25% in 5-mL increments will be injected, aspirating gently between injections. The needle will be withdrawn to place the tip in the fascial plane between the pectoralis major and pectoralis minor muscles and ropivacaine 0.25%, 10 ml in 5 ml increments will be injected. Injectate spread between the muscles will be visualized. For patients in control group, no nerve block will be performed and only intravenous nalbuphine will be given.

Procedure: PECS Block

Control Group

ACTIVE COMPARATOR

For patients in control group, after induction of general anesthesia, no nerve block will be performed and only intravenous nalbuphine will be given.

Other: Control Group

Interventions

PECS Block PROCEDURE

PECS nerve block will be performed using the ultrasound-guided technique described by Blanco and colleagues. Block will be performed with a 22-gauge 100 mm needle (Stimuplex, B. Braun Medical Inc., Pennsylvania, USA) using Mindray M7 imaging system (Diagnostic Instruments Inc., China) with a high-frequency (6-13 MHz) linear array transducer.20 mL of ropivacaine 0.25% in 5-mL increments will be injected, aspirating gently between injections. The needle will be withdrawn to place the tip in the fascial plane between the pectoralis major and pectoralis minor muscles and ropivacaine 0.25%, 10 ml in 5 ml increments will be injected. Injectate spread between the muscles will be visualized. For patients in control group, no nerve block will be performed and only intravenous nalbuphine will be given.

PECS block

Control Group OTHER

No nerve block will be performed and only intravenous nalbuphine will be given.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective modified radical mastectomy (MRM)
• All adults aged between 18 and 65 years
• ASA (American Society of Anesthesiologists ) I \& II

You may not qualify if:

• Patient refusal
• Hypersensitivity to local anaesthetics
• Coagulopathy or bleeding diathesis
• Local infection at the site of block
• BMI more than 35 kg/m2
• Chest wall deformity or previous breast surgery
• MRM with latissimus dorsi or deep inferior epigastric perforator flap reconstruction

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (4)

• Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

  PMID: 25376971 BACKGROUND

• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

  PMID: 22939099 BACKGROUND

• M N, Pandey RK, Sharma A, Darlong V, Punj J, Sinha R, Singh PM, Hamshi N, Garg R, Chandralekha C, Srivastava A. Pectoral nerve blocks to improve analgesia after breast cancer surgery: A prospective, randomized and controlled trial. J Clin Anesth. 2018 Mar;45:12-17. doi: 10.1016/j.jclinane.2017.11.027. Epub 2017 Dec 11.

  PMID: 29241077 BACKGROUND

• Morioka H, Kamiya Y, Yoshida T, Baba H. Pectoral nerve block combined with general anesthesia for breast cancer surgery: a retrospective comparison. JA Clin Rep. 2015;1(1):15. doi: 10.1186/s40981-015-0018-1. Epub 2015 Sep 23.

  PMID: 29497647 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia; Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Faisal Shamim, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Anaesthesiology

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 13, 2020
• Study Start: November 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

PA (1)