NCT02747992

Brief Summary

Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 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

October 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

4 months

First QC Date

April 17, 2016

Last Update Submit

April 19, 2016

Conditions

Mastectomy, Modified Radical

Outcome Measures

Primary Outcomes (1)

  • intraoperative sedation requirement

    target controlled infusion (TCI) propofol driven by the Schnider model in effect site control titrated to reach conscious sedation defined as Observer Assessment of Alertness/Sedation score of 2 to 3

    during operation

Secondary Outcomes (3)

  • time to first request of analgesics

    postoperative 12 hours

  • postoperative analgesic requirement

    postoperation to discharge

  • side effects

    postoperation to within 24 hours after discharge

Study Arms (2)

PECS 0

receiving paravertebral block

PECS 1

receiving paravertebral block and blocks targeting pectoral musculature

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible patients were that diagnosed to have unilateral breast cancer and undergone modified radical mastectomy using regional anesthesia during Jun 1, 2012 and May 31, 2015.

You may qualify if:

  • The American Society of Anesthesiologists (ASA) Physical Status classification I to III
  • years of age
  • female gender

You may not qualify if:

  • body mass index (BMI) ≥ 35 kg/m2
  • modified radical mastectomy not performed by the single surgeon (Ben Long Yu)
  • anesthesia not performed by the single anesthesiologist (Nai Liang Li)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 17, 2016

First Posted

April 22, 2016

Study Start

October 1, 2015

Primary Completion

February 1, 2016

Last Updated

April 22, 2016

Record last verified: 2016-04