NCT04095897

Brief Summary

Post mastectomy pain syndrome (PMPS) is a chronic pain condition that develops after breast cancer surgery. The objective of this study was to determine if Pecs II block administered prior to general anesthesia (GA) reduced the incidence of PMPS after mastectomy and axillary clearance (MAC) when compared with conventional analgesic therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 6, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 17, 2019

Last Update Submit

September 18, 2019

Conditions

Chronic Pain

Keywords

PMPSPecs IIPectoral Nerve BlockCPSP

Outcome Measures

Primary Outcomes (1)

  • Incidence of PMPS

    Incidence of Post mastectomy pain syndrome (PMPS)

    2 years

Secondary Outcomes (1)

  • Severity of PMPS

    2 years

Study Arms (2)

conventional analgesic therapy

Patient underwent mastectomy with conventional analgesic therapy

Pecs II block

Patient underwent mastectomy with conventional analgesic therapy with pre induction Pecs II block

Procedure: Pecs II Block

Interventions

Pecs II BlockPROCEDURE

Peripheral nerve block - Regional anesthesia : Pectoral Nerve block type 2

Pecs II block

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient underwent unilateral mastectomy for breast carcinoma

You may qualify if:

  • patient underwent unilateral mastectomy for breast carcinoma

You may not qualify if:

  • past history of chronic pain and on regular analgesics, chemotherapy or radiotherapy before surgery, surgical complications (such as infection or wound breakdown) or cancer recurrence, history of psychiatric illness, inability to be contacted, inability or unwillingness to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Center

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • YEOH CHIH NIE, Mmed

    Universiti Kebangsaan Malaysia Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

March 6, 2018

Primary Completion

December 28, 2018

Study Completion

February 20, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

MY(1)