Prospectively Assessing Pain After Breast Surgery

Not yet recruiting

• Conditions: Pain, Postoperative

• Registration Number: NCT05210400
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27
• Study Start: 2022-03-01
• Primary Completion: 2024-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of narcotic pain pills used after surgery	Assessed approximately a week after surgery
Pain scores in recovery room	The day of surgery	EMR documentation from the recovery room