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Clinical Trials/NCT05210400
NCT05210400
Not yet recruiting
Not Applicable

Prospectively Assessing Pain After Breast Surgery

Cedars-Sinai Medical Center0 sites40 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Cedars-Sinai Medical Center
Enrollment
40
Primary Endpoint
Number of narcotic pain pills used after surgery
Status
Not yet recruiting
Last Updated
4 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
February 28, 2025
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Scott Karlan

M.D.

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Number of narcotic pain pills used after surgery

Time Frame: Assessed approximately a week after surgery

Pain scores in recovery room

Time Frame: The day of surgery

EMR documentation from the recovery room

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