Clinical trial NCT03602794: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mastectomy; Lymphedema
Local Infiltration
Anesthesia, Local
Block
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Total morphine consumption in 24 hour after surgery
timeFrame: 24 hour
Secondary outcomes:
measure: Duration of analgesia
timeFrame: 24 hours
measure: Postoperative pain score.
timeFrame: 24 hours
measure: Adverse Effects
timeFrame: 24 hours
measure: Postoperative nausea vomiting (PONV)
timeFrame: 24 hours
measure: Intraoperative analgesia
timeFrame: 24 hours
measure: Operative time
timeFrame: 24 hrs
measure: Block performance time
timeFrame: 24 hours
measure: Block related complications
timeFrame: 24 hours
measure: Block related complications
timeFrame: 24 hours
measure: Block related complications
timeFrame: 24 hours
measure: Post-operative complications
timeFrame: 24 hours
measure: Post-operative complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Kwee Lian Woon
role: PRINCIPAL_INVESTIGATOR
References:
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.