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

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04343807
• Other study ID #: 3543
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: Aga Khan University
• Contact: Faisal Shamim, FCPS
• Phone: 021-34864639
• Email: faisal.shamim[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anaesthesia
• Analgesia
• Breast Cancer
• Breast Neoplasm Female
• Breast Neoplasms
• Pain
• Pain, Postoperative

Intervention

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.

Other:
• Control Group
No nerve block will be performed and only intravenous nalbuphine will be given.

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total intraoperative opioid consumption	Total intraoperative nalbuphine	During surgical procedure
Primary	Total postoperative opioid consumption	Total Rescue Tramadol Consumption	First 24 hours after surgery
Secondary	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
Secondary	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
Secondary	Postoperative nausea and vomiting	Yes or No	First 24 hours after surgery