NCT02555423

Brief Summary

The aim of the study is to determine the effectiveness of serratus place block in the control of post-operative pain following mastectomy. The investigators will compare one group of patients receiving serratus plane block and wound infiltration to a control group receiving a saline injection into serratus anterior and wound infiltration with local anaesthetic only. The investigators will compare our results to the National Mastectomy and Breast Reconstruction Audit's reported rate of 6.2% of patients reporting severe pain following mastectomy to see if there is an improvement of the national standard. In the serratus block group, the investigators expect a 50% decrease in the number of patients who report severe pain day one post operatively.

Trial Health

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Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

1.5 years

First QC Date

September 17, 2015

Last Update Submit

September 18, 2015

Conditions

Post-operative PainSerratus BlockBreast Surgery

Outcome Measures

Primary Outcomes (1)

  • To assess the serratus plane block's effectiveness in the management of post operative pain following mastectomy when compared to wound infiltration alone

    18 months

Secondary Outcomes (1)

  • To determine the proportion of patients receiving a serratus plane block during mastectomy who go on to develop chronic pain syndromes compared to patients receiving wound infiltration alone

    18 months

Interventions

Local anaesthetic - chirocaineDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergo mastectomy +/- sentinel node biopsy +/- axillary clearance +/- implant reconstruction will be eligible for the study

You may not qualify if:

  • Patients under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 21, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2017

Last Updated

September 21, 2015

Record last verified: 2015-09