RecruitingPhase 4NCT06574022

Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks

Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks


Sponsor

University of Cincinnati

Enrollment

100 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two different approaches to nerve blocks for pain relief after a mastectomy (breast removal surgery): one given before the operation (preoperative PECS-II block) versus one given during the operation (intraoperative pectoral block). Nerve blocks numb the chest area and reduce the need for opioids after surgery. **You may be eligible if...** - You are 18 or older - You are undergoing mastectomy with or without axillary surgery or reconstruction for breast cancer or high risk of breast cancer (e.g., BRCA mutation) **You may NOT be eligible if...** - You are having a partial mastectomy (lumpectomy) or tissue-only reconstruction - You do not speak English - You are pregnant - You have an allergy to local anesthetics (note: allergy to topical anesthetics only is acceptable) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBupivacain

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.

DRUGExparel

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.

PROCEDUREIntraoperative Pecs II block (IOB) & superior AT (EX or BP)

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.

PROCEDUREPreoperative Pecs II block (POB) & superior AT (EX or BP)

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.


Locations(1)

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

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NCT06574022


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