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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05210400
Other study ID # STUDY00001859
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date February 28, 2025

Study information

Verified date January 2022
Source Cedars-Sinai Medical Center
Contact Scott Karlan, M.D.
Phone 310-423-9331
Email Scott.Karlan@cshs.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Breast surgeons may be able to reduce post-operative pain and the need for opioid narcotics by utilizing regional anesthesia techniques (modified regional blocks) during surgery. To test this hypothesis, we need baseline (pre-intervention) data on how much pain patients experience when breast surgery is done without blocks. In this study, we will gather data on (1.) pain pills used after surgery, and (2.) pain scores in the recovery room. This will allow us to establish how much pain normally occurs after axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy, done by a participating breast surgeon. After analyzing this data, our plan is to do a second study, with a new group of patients, to assess whether there is any change in outcome after surgeons implement these new techniques.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date February 28, 2025
Est. primary completion date February 28, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Female, age 18 or older. 4. Scheduled for axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy. 5. Able to take oral narcotics and be willing to adhere to the prescribed regimen. Exclusion Criteria: 1. A history of chronic pain 2. Any previously diagnosed chronic pain syndrome. 3. Prior use of narcotics, on more than 5 days in the past 3 months or 10 days in the past year.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Pain scores in recovery room EMR documentation from the recovery room The day of surgery
Primary Number of narcotic pain pills used after surgery Assessed approximately a week after surgery
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