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

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ClinicalTrials.gov Identifier: NCT04343807
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : February 1, 2023
Sponsor:
Information provided by (Responsible Party):
Faisal Shamim, Aga Khan University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Neoplasm Female Pain, Postoperative Pain Analgesia Anaesthesia Breast Cancer Procedure: PECS Block Other: Control Group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Patient Satisfaction [ Time Frame: First 24 hours after surgery ]

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

    1. = Not Satisfied
    2. = Good or satisfied
    3. = 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343807


Contacts
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Contact: Faisal Shamim, FCPS 021-34864639 faisal.shamim@aku.edu
Contact: Malika H. Dhanani, FCPS 021-34864715 malika.hameed@gmail.com

Locations
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Pakistan
Aga Khan University Hospital Recruiting
Karachi, Sindh, Pakistan
Contact: Dr. Faisal Shamim, FCPS Anesthesiology    021-34861452    faisal.shamim@aku.edu   
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Faisal Shamim, FCPS Aga Khan University
More Information
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Publications:

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Responsible Party: Faisal Shamim, Associate Professor Anaesthesiology, Aga Khan University
ClinicalTrials.gov Identifier: NCT04343807    
Other Study ID Numbers: 3543
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: February 1, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Pain, Postoperative
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations