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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Pain, Postoperative; Breast Cancer; Anaesthesia; Analgesia; Breast Neoplasm Female
• Intervention / Treatment: Procedure: PECS Block; Other: Control Group

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Faisal Shamim, FCPS; Phone Number: 021-34864639; Email: faisal.shamim@aku.edu
• Study Contact Backup: Name: Malika H. Dhanani, FCPS; Phone Number: 021-34864715; Email: malika.hameed@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Recruiting
      • Aga Khan University Hospital
      • Contact: Dr. Faisal Shamim, FCPS Anesthesiology; Phone Number: 021-34861452; Email: faisal.shamim@aku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PECS block; 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; 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.
Active Comparator: Control Group; 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; No nerve block will be performed and only intravenous nalbuphine will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative opioid consumption	Total intraoperative nalbuphine	During surgical procedure
Total postoperative opioid consumption	Total Rescue Tramadol Consumption	First 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction with post-operative analgesia will be noted via satisfaction scoring i.e.: = Not Satisfied; = Good or satisfied; = Excellent or very satisfied	First 24 hours after surgery
Postoperative pain score	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).	1, 6,12 and 24 hours after surgery
Postoperative nausea and vomiting	Yes or No	First 24 hours after surgery

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Faisal Shamim, FCPS, Aga Khan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Pain, Postoperative; Breast Neoplasms
• Other Study ID Numbers: 3543

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No