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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Local; Mastectomy; Lymphedema; Block; Local Infiltration
• Intervention / Treatment: Procedure: PECs Block; Procedure: Local infiltration

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Recruiting
    • Changi General Hospital
    • Contact: Kwee Lian Woon; Phone Number: +65 81211037

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PECs Block; 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	Procedure: PECs Block; Regional Anaesthesia Technique ie Pectoralis Nerve Block under ultrasound guidance
PLACEBO_COMPARATOR: Local Infiltration; 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.	Procedure: Local infiltration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption in 24 hour after surgery	Total morphine consumption in 24 hour after surgery	24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	time to first rescue analgesia after administration of block	24 hours
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	24 hours
Adverse Effects	Any adverse effects will be recorded (such as hypotension, respiratory depression, pruritus, shivering and urinary retention)	24 hours
Postoperative nausea vomiting (PONV)	Postoperative nausea vomiting (PONV)	24 hours
Intraoperative analgesia	total usage of IV Fentanyl intraoperatively	24 hours
Operative time	duration of surgery	24 hrs
Block performance time	time from needle insertion until needle exit from the skin	24 hours
Block related complications	pneumothorax	24 hours
Block related complications	vascular puncture	24 hours
Block related complications	local anaesthetic toxicity	24 hours
Post-operative complications	Bleeding	24 hours
Post-operative complications	Wound infection	24 hours

Collaborators and Investigators

• Sponsor: Louis Ng Xiang Long
• Investigators: Principal Investigator: Kwee Lian Woon, Changi General Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Ultrasound description of Pecs II (modified Pecs I): A novel approacj to breast surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ANTICIPATED): July 16, 2019
• Study Completion (ANTICIPATED): July 16, 2019

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (ACTUAL): July 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 2017/2894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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