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NCT06574022PHASE4Recruiting

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

University of Cincinnati

Start Date

9/25/2024

Completion Date

12/1/2026

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.

Detailed Description

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. Standard of care intervention is preoperative PECS-II blocks versus Intraoperative Pectoral Blocks. The medication used are standard of care and include Bupivacaine and liposomal bupivacaine. Bupivacaine is FDA approved and indicated for the local or regional anesthesia or analgesia for surgery procedures and therapeutic procedures. Liposomal bupivacaine is FDA approved and indicated for adults to produce postsurgical local analgesia and as nerve block to produce postsurgical regional analgesia.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patients who are 18 years of age or older * Patients undergoing mastectomy with or without axillary surgery, with or without reconstruction surgery at UCMC for breast cancer or high-risk of breast cancer. Patients with high-risk of breast cancer are those who have atypical/precancerous breast lesion(s), genetic mutation with increased risk of cancer (e.g., BRCA1, BRCA2 etc..) and/or a strong family history of breast cancer in the opinion of the investigator. Exclusion Criteria: * Patients undergoing only a partial mastectomy or tissue-based reconstruction. * 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. * Patients with a preoperative acute or chronic pain disorder with an opioid prescription that has been prescribed within 30 days of surgery. Patients who have not filled such a prescription or who state they have not taken the medications prescribed, may be eligible on a case-by-case basis per investigator judgement. * Patients with a history of opioid use disorder. * Inability to provide informed consent. * Patients who otherwise in the opinion of the Investigator are not good candidates for participation (e.g., deemed unreliable for follow-up).

Interventions

DRUG

Bupivacain

DRUG

Exparel

PROCEDURE

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

PROCEDURE

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

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Conditions

Mastectomy; LymphedemaBreast Cancer

Locations

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States