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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

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days post operation

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met