Status:

RECRUITING

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

Lead Sponsor:

University of Cincinnati

Conditions:

Mastectomy; Lymphedema

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 to...

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 to...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

September 25 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06574022

Start Date

September 25 2024

End Date

December 1 2026

Last Update

November 4 2025

Active Locations (1)

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1

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219