Skip to main content
OpenTrials
Completed

NCT Number: NCT04343807

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasm Female Agnosia Anaesthesia Analgesia Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University Hospital

Karachi, Sindh, Pakistan

About this study

The traditional pain management for patients undergoing MRM has relied heavily on opioids but a number of multimodal pain control strategies also exist including combining opioids with NSAIDs, cyclooxygenase-2 inhibitors, acetaminophen and regional blocks. Recently, literature underlines the importance of performing regional anaesthetic and analgesic techniques for postoperative analgesia following breast surgery. PECS (Pectoral nerve block) block provides analgesia for breast surgeries with few adverse effects.

OBJECTIVES To evaluate the effect of ultrasound guided pectoral block in reducing intraoperative and postoperative opioid consumption following modified radical mastectomy.

The secondary objective is to determine patient satisfaction levels associated with adequate pain control.

HYPOTHESIS Pectoral nerve blocks provides superior analgesia with less opioid consumption and improves patient satisfaction in postoperative period compared to conventional pain management for modified radical mastectomy patients

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Control Group

Other

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

Primary outcomes

  1. Total intraoperative opioid consumption

    Time frame: During surgical procedure

    Total intraoperative nalbuphine

  2. Total postoperative opioid consumption

    Time frame: First 24 hours after surgery

    Total Rescue Tramadol Consumption

Secondary outcomes

  1. Patient Satisfaction

    Time frame: First 24 hours after surgery

    Patient satisfaction with post-operative analgesia will be noted via satisfaction scoring i.e.:

    • = Not Satisfied
    • = Good or satisfied
    • = Excellent or very satisfied

  2. Postoperative pain score

    Time frame: 1, 6,12 and 24 hours after surgery

    Numeric rating scale for pain assessment: Patient will be asked to rate their intensity of pain on numeric scale from 0 (no pain) to 10 (worst possible pain).

  3. Postoperative nausea and vomiting

    Time frame: First 24 hours after surgery

    Yes or No

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 13, 2020
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.