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Clinical Trials/NCT03602794
NCT03602794
Unknown
Not Applicable

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

Louis Ng Xiang Long1 site in 1 country40 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mastectomy; Lymphedema
Sponsor
Louis Ng Xiang Long
Enrollment
40
Locations
1
Primary Endpoint
Total morphine consumption in 24 hour after surgery
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
July 16, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Louis Ng Xiang Long
Responsible Party
Sponsor Investigator
Principal Investigator

Louis Ng Xiang Long

Co- Investigator

Changi General Hospital

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

Outcomes

Primary Outcomes

Total morphine consumption in 24 hour after surgery

Time Frame: 24 hour

Total morphine consumption in 24 hour after surgery

Secondary Outcomes

  • Duration of analgesia(24 hours)
  • Postoperative pain score.(24 hours)
  • Adverse Effects(24 hours)
  • Postoperative nausea vomiting (PONV)(24 hours)
  • Intraoperative analgesia(24 hours)
  • Operative time(24 hrs)
  • Block performance time(24 hours)
  • Block related complications(24 hours)
  • Post-operative complications(24 hours)

Study Sites (1)

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