Prospectively Assessing Pain After Breast Surgery

Pain, Postoperative Clinical Trial

Official title:

Prospectively Assessing Pain After Breast Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05210400
• Other study ID #: STUDY00001859
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Pain, Postoperative

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