Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
Recruiting · NCT06574022 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Cincinnati
View the official record on ClinicalTrials.gov →Interventions studied
BupivacainExparelIntraoperative Pecs II block (IOB) & superior AT (EX or BP)Preoperative Pecs II block (POB) & superior AT (EX or BP)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed across 1 US state.
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States