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NCT06574022 | NOT YET RECRUITING | Mastectomy; Lymphedema

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

University of Cincinnati

Information provided by (Responsible Party):

Alicia Heelan

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 total mastectomy.

Condition or disease

Mastectomy; Lymphedema

Breast Cancer

Intervention/treatment

Bupivacain

Exparel

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

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

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
Actual Study Start Date : 2024-09-01
Estimated Primary Completion Date : 2026-08-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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).
Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks

Location Details

NCT06574022

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How to Participate

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Locations

Not yet recruiting

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219