NCT03602794

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

July 18, 2018

Last Update Submit

September 3, 2018

Conditions

Mastectomy; LymphedemaLocal InfiltrationAnesthesia, LocalBlock

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption in 24 hour after surgery

    Total morphine consumption in 24 hour after surgery

    24 hour

Secondary Outcomes (12)

  • Duration of analgesia

    24 hours

  • Postoperative pain score.

    24 hours

  • Adverse Effects

    24 hours

  • Postoperative nausea vomiting (PONV)

    24 hours

  • Intraoperative analgesia

    24 hours

  • +7 more secondary outcomes

Study Arms (2)

PECs Block

ACTIVE COMPARATOR

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

Local Infiltration

PLACEBO COMPARATOR

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

Interventions

PECs BlockPROCEDURE

Regional Anaesthesia Technique ie Pectoralis Nerve Block under ultrasound guidance

PECs Block
Local infiltrationPROCEDURE

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.

Local Infiltration

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22939099BACKGROUND

Related Links

MeSH Terms

Conditions

LymphedemaBites and Stings

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Kwee Lian Woon

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwee Lian Woon

CONTACT

+6581211037Kwee_Lian_Woon@cgh.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised Controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co- Investigator

Study Record Dates

First Submitted

July 18, 2018

First Posted

July 27, 2018

Study Start

August 1, 2018

Primary Completion

July 16, 2019

Study Completion

July 16, 2019

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)