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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two standard ways to numb the chest area and manage pain: one before surgery and one during surgery. It is for adults having a total mastectomy (surgery to remove the whole breast) at UCMC because they have breast cancer or a high risk of it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You will have a mastectomy at UCMC for breast cancer or a high risk of breast cancer. Surgery may also include the underarm area or rebuilding the breast.
  • High risk may mean breast changes that could become cancer, a gene change that raises cancer risk (such as BRCA1 or BRCA2), or a strong family history, as judged by the study doctor.

Who can't join

  • You will have only part of the breast removed, or the breast will be rebuilt using body tissue.
  • You do not speak English.
  • You are pregnant.
  • You are allergic to local numbing medicines. You may still qualify if you are allergic only to numbing medicines put on the skin.
  • You have a pain condition before surgery and were prescribed an opioid pain medicine within 30 days of surgery. If you did not fill the prescription or take the medicine, the study doctor may still allow you to join.
  • You have a history of opioid use disorder (trouble controlling opioid use).
  • You cannot give informed consent, meaning you cannot understand the study and agree to join.
  • The study doctor thinks you are not a good fit, such as if you may not complete follow-up visits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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).

Study sites (1)

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