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Prospectively Assessing Pain After Breast Surgery

Cedars-Sinai Medical Center logo

Cedars-Sinai Medical Center

Status

Not yet enrolling

Conditions

Pain, Postoperative

Study type

Observational

Funder types

Other

Identifiers

NCT05210400
STUDY00001859

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

0

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Central trial contact

Scott Karlan, M.D.

Data sourced from clinicaltrials.gov

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