NCT05210400

Brief Summary

Reducing post-operative pain and reducing the use of opioid narcotics are independently valuable goals. Before studying newer techniques that may help us achieve these goals, we need objective data on how much pain normally occurs after breast surgery done with standard-of-care techniques. This study was designed to obtain baseline data.

Trial Health

35
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 all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

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

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 14, 2022

Last Update Submit

January 14, 2022

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

  • Pain scores in recovery room

    EMR documentation from the recovery room

    The day of surgery

  • Number of narcotic pain pills used after surgery

    Assessed approximately a week after surgery

Eligibility Criteria

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

Recruitment will depend on referral by one of the study co-investigators, at the time that they schedule a patient for axillary surgery with or without concurrent lumpectomy.

You may qualify if:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Female, age 18 or older.
  • Scheduled for axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy.
  • Able to take oral narcotics and be willing to adhere to the prescribed regimen.

You may not qualify if:

  • A history of chronic pain
  • Any previously diagnosed chronic pain syndrome.
  • Prior use of narcotics, on more than 5 days in the past 3 months or 10 days in the past year.

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

Central Study Contacts

Scott Karlan, M.D.

CONTACT

310-423-9331Scott.Karlan@cshs.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

March 1, 2022

Primary Completion

February 28, 2024

Study Completion

February 28, 2025

Last Updated

January 27, 2022

Record last verified: 2022-01