Pain Management Blocks for Mastectomy in Breast Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Cincinnati

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.

Eligibility Criteria

This trial is for breast cancer patients preparing for a total mastectomy. It's designed to compare pain management and local anesthesia methods post-surgery. Specific eligibility details are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

I am 18 years old or older.

I am having a mastectomy at UCMC due to breast cancer or a high risk of it.

Exclusion Criteria

Non-English speaking

Patients who are pregnant

Patients with an allergy to local anesthetics (Except: patients with allergies only to topical anesthetics may be included)

+5 more

Participant Groups

The study is testing two pain management approaches: one using Exparel with an intraoperative Pecs II block (IOB) and superior AT, the other using Bupivacain with a preoperative Pecs II block (POB) and superior AT.

4Treatment groups

Active Control

Group I: 1) Intraoperative Pecs Blocks (IOB) & 30 cc of 0.5% bupivacaine (PB)Active Control1 Intervention

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 30 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.

Group II: 2) Intraoperative Pecs Blocks (IOB) & 20 cc of Exparel mixed w/10 cc of 0.5% bupivacaine (EX)Active Control1 Intervention

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 20 cc of Exparel mixed with 10 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.

Group III: 3) Intraoperative Pecs II block (IOB) & superior AT (EX or BP)Active Control1 Intervention

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle with superior anesthetic as determined by stage I, after mastectomy completion and prior to reconstruction, if performed, or wound closure.

Group IV: 4) Preoperative Pecs II block (POB) & superior AT (EX or BP)Active Control1 Intervention

Preoperative Pecs II block to be administered by 1 of 6 acute pain specialized anesthesiologists in same day surgery. Patient will be lightly sedated with midazolam, at the discretion of the anesthesiologist. The pecs II block will be performed under ultrasound guidance using a 21-gauge, 80 mm length needle to administer the superior anesthetic as determined in stage I.