NCT02963857

Brief Summary

This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 10, 2016

Last Update Submit

November 16, 2016

Conditions

Mastectomy, SegmentalAcute PainAnesthesia

Keywords

breast surgeryacute painregional anesthesia

Outcome Measures

Primary Outcomes (1)

  • The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.

    3 days

Secondary Outcomes (2)

  • Pain levels on a numeric pain rating scale were recorded at rest and with arm mobilization during the first 72 hours.

    3 days

  • level of comfort during the first 72 hours was recorded (the 4 levels-scale used was: excellent, good, medium and bad).

    3 days

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients included in the study have had a total mastectomy surgery with a complete axillary lymph nodes removal.

You may qualify if:

  • total mastectomy surgery with a complete axillary lymph nodes removal

You may not qualify if:

  • age under 18
  • contraindication to the surgery
  • refusal of the protocol by the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Claude-Charles Balick-Weber, MD

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 15, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share