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Local Anesthetic

Pain Management Blocks for Mastectomy in Breast Cancer

Phase 4
Waitlist Available
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are 18 years of age or older
Be older than 18 years old
Must not have
Patients undergoing only a partial mastectomy or tissue-based reconstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days post operation
Awards & highlights

Summary

This trial aims to compare two different ways of managing pain and using local numbing medicine for breast cancer patients undergoing a total mastectomy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include reactions at the injection site, such as swelling or pain, potential nerve injury from the block procedure, nausea or vomiting from anesthesia drugs, and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am having a partial mastectomy or tissue-based breast reconstruction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days post operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days post operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative pain as indicated by postoperative opioid use discontinuation
Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents)
Secondary study objectives
Intraoperative opioid administration measured in Milliequivalents
Intraoperative procedure time measured as from time of incision to start of closing
Operating room delays measured as anesthesia start time that is greater than 1 hour after the scheduled start time
+4 more

Trial Design

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.

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Who is running the clinical trial?

University of CincinnatiLead Sponsor
433 Previous Clinical Trials
636,303 Total Patients Enrolled
2 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer
~67 spots leftby Aug 2026
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