search
Back to results

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

Primary Purpose

Breast Neoplasm Female, Pain, Postoperative, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
PECS Block
Control Group
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Neoplasm Female

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Aga Khan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PECS block

Control Group

Arm Description

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 The needle will be withdrawn to place the tip in the fascial plane between the pectoralis major and pectoralis minor muscles and ropivacaine 0.25%, 10 ml in 5 ml increments will be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.

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

Outcomes

Primary Outcome Measures

Total intraoperative opioid consumption
Total intraoperative nalbuphine
Total postoperative opioid consumption
Total Rescue Tramadol Consumption

Secondary Outcome Measures

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
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).
Postoperative nausea and vomiting
Yes or No

Full Information

First Posted
April 10, 2020
Last Updated
January 31, 2023
Sponsor
Aga Khan University
search

1. Study Identification

Unique Protocol Identification Number
NCT04343807
Brief Title
Effectiveness of Ultrasound Guided PECS Block on Opioid Consumption and Patient Satisfaction Through Adequate Pain Control Following Breast Cancer Surgery.
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Pain, Postoperative, Pain, Analgesia, Anaesthesia, Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PECS block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
For patients in control group, after induction of general anesthesia, no nerve block will be performed and only intravenous nalbuphine will be given.
Intervention Type
Procedure
Intervention Name(s)
PECS Block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
No nerve block will be performed and only intravenous nalbuphine will be given.
Primary Outcome Measure Information:
Title
Total intraoperative opioid consumption
Description
Total intraoperative nalbuphine
Time Frame
During surgical procedure
Title
Total postoperative opioid consumption
Description
Total Rescue Tramadol Consumption
Time Frame
First 24 hours after surgery
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Patient satisfaction with post-operative analgesia will be noted via satisfaction scoring i.e.: = Not Satisfied = Good or satisfied = Excellent or very satisfied
Time Frame
First 24 hours after surgery
Title
Postoperative pain score
Description
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).
Time Frame
1, 6,12 and 24 hours after surgery
Title
Postoperative nausea and vomiting
Description
Yes or No
Time Frame
First 24 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faisal Shamim, FCPS
Phone
021-34864639
Email
faisal.shamim@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Malika H. Dhanani, FCPS
Phone
021-34864715
Email
malika.hameed@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faisal Shamim, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Faisal Shamim, FCPS Anesthesiology
Phone
021-34861452
Email
faisal.shamim@aku.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
25376971
Citation
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.
Results Reference
background
PubMed Identifier
22939099
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.
Results Reference
background
PubMed Identifier
29241077
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.
Results Reference
background
PubMed Identifier
29497647
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs