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A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study

Primary Purpose

Mastectomy; Lymphedema, Local Infiltration, Anesthesia, Local

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
PECs Block
Local infiltration
Sponsored by
Louis Ng Xiang Long
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mastectomy; Lymphedema

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age above 21 years old
  • Able to give consent
  • Body weight > 50kg

Exclusion Criteria:

  • Patient's refusal and inability to give consent
  • Allergy or contraindicated to local anaesthetics, paracetamol, NSAIDS or opioids
  • Background history of chronic pain
  • Bilateral procedures

Sites / Locations

  • Changi General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PECs Block

Local Infiltration

Arm Description

Total local anaesthetic dose: 30ml ropivacaine 0.5% •Pecs block will be performed by anaesthetist using ultrasound guidance in plane approach: 10ml ropivacaine 0.5% will be delivered at the plane between pectoralis major and pectoralis minor, another 20ml ropivacaine 0.5% will be delivered in the plane between the pectoralis minor and serratus anterior muscles at the level of the third and fourth ribs

LIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles.

Outcomes

Primary Outcome Measures

Total morphine consumption in 24 hour after surgery
Total morphine consumption in 24 hour after surgery

Secondary Outcome Measures

Duration of analgesia
time to first rescue analgesia after administration of block
Postoperative pain score.
Post op pain score will be assessed using a visual analogue scale (VAS, 0-10; 0 = no pain and 10 = worst imaginable pain). The vital signs and pain score will be recorded at 0, 0.5, 1, 2, 4, 6, 8, 12, and 24 h after surgery by the attending staff nurses blinded to the group allocation
Adverse Effects
Any adverse effects will be recorded (such as hypotension, respiratory depression, pruritus, shivering and urinary retention)
Postoperative nausea vomiting (PONV)
Postoperative nausea vomiting (PONV)
Intraoperative analgesia
total usage of IV Fentanyl intraoperatively
Operative time
duration of surgery
Block performance time
time from needle insertion until needle exit from the skin
Block related complications
pneumothorax
Block related complications
vascular puncture
Block related complications
local anaesthetic toxicity
Post-operative complications
Bleeding
Post-operative complications
Wound infection

Full Information

First Posted
July 18, 2018
Last Updated
September 3, 2018
Sponsor
Louis Ng Xiang Long
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1. Study Identification

Unique Protocol Identification Number
NCT03602794
Brief Title
A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study
Official Title
A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
July 16, 2019 (Anticipated)
Study Completion Date
July 16, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Louis Ng Xiang Long

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
The investigators aim to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance for patients undergoing mastectomy with axillary dissection.
Detailed Description
Total breast removal with armpit dissection may be a painful surgery. Pectoral nerve block (Pecs block) is common pain relief method used to reduce pain after breast surgery. The Pecs block is a pain relief method technique at targeted body part. The Pecs block numbs nerves which supply sensation to the upper chest wall, armpit and upper arm. This procedure is only possible under ultrasound guidance and is carried out by the anaesthetist (medical specialist who administers anaesthetics) after patients are put under general anaesthesia. Despite the advantages of Pecs block in pain management, this method is not always available to all patients due to various reasons. These reasons include the availability of ultrasound machine to facilitate the method, presence of anaesthetist to carry out the procedure and additional time required to perform this method in the operating theatre. Another method has been modified by our surgeons (medical specialist who performs surgery, a different specialty from anaesthetist) to achieve pain relief among patients undergoing breast removal surgery. This method is called local infiltration analgesia (LIA). The pain control is achieved by having the surgeons to deliver a pain control drug surgically during the breast removal operation. LIA could be a good pain control alternative when a Pecs block could not be performed. The investigators hope to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance. The investigators hope to show that LIA delivered by surgeon is as effective as Pecs block in patients undergoing mastectomy with axillary dissection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy; Lymphedema, Local Infiltration, Anesthesia, Local, Block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PECs Block
Arm Type
Active Comparator
Arm Description
Total local anaesthetic dose: 30ml ropivacaine 0.5% •Pecs block will be performed by anaesthetist using ultrasound guidance in plane approach: 10ml ropivacaine 0.5% will be delivered at the plane between pectoralis major and pectoralis minor, another 20ml ropivacaine 0.5% will be delivered in the plane between the pectoralis minor and serratus anterior muscles at the level of the third and fourth ribs
Arm Title
Local Infiltration
Arm Type
Placebo Comparator
Arm Description
LIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles.
Intervention Type
Procedure
Intervention Name(s)
PECs Block
Intervention Description
Regional Anaesthesia Technique ie Pectoralis Nerve Block under ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
Local infiltration
Intervention Description
LIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles.
Primary Outcome Measure Information:
Title
Total morphine consumption in 24 hour after surgery
Description
Total morphine consumption in 24 hour after surgery
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Duration of analgesia
Description
time to first rescue analgesia after administration of block
Time Frame
24 hours
Title
Postoperative pain score.
Description
Post op pain score will be assessed using a visual analogue scale (VAS, 0-10; 0 = no pain and 10 = worst imaginable pain). The vital signs and pain score will be recorded at 0, 0.5, 1, 2, 4, 6, 8, 12, and 24 h after surgery by the attending staff nurses blinded to the group allocation
Time Frame
24 hours
Title
Adverse Effects
Description
Any adverse effects will be recorded (such as hypotension, respiratory depression, pruritus, shivering and urinary retention)
Time Frame
24 hours
Title
Postoperative nausea vomiting (PONV)
Description
Postoperative nausea vomiting (PONV)
Time Frame
24 hours
Title
Intraoperative analgesia
Description
total usage of IV Fentanyl intraoperatively
Time Frame
24 hours
Title
Operative time
Description
duration of surgery
Time Frame
24 hrs
Title
Block performance time
Description
time from needle insertion until needle exit from the skin
Time Frame
24 hours
Title
Block related complications
Description
pneumothorax
Time Frame
24 hours
Title
Block related complications
Description
vascular puncture
Time Frame
24 hours
Title
Block related complications
Description
local anaesthetic toxicity
Time Frame
24 hours
Title
Post-operative complications
Description
Bleeding
Time Frame
24 hours
Title
Post-operative complications
Description
Wound infection
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age above 21 years old Able to give consent Body weight > 50kg Exclusion Criteria: Patient's refusal and inability to give consent Allergy or contraindicated to local anaesthetics, paracetamol, NSAIDS or opioids Background history of chronic pain Bilateral procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwee Lian Woon
Phone
+6581211037
Email
Kwee_Lian_Woon@cgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwee Lian Woon
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwee Lian Woon
Phone
+65 81211037

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Links:
URL
http://dx.doi.org/10.1016/j.redar.2012.07.003
Description
Ultrasound description of Pecs II (modified Pecs I): A novel approacj to breast surgery

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A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study

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