MedPath

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

Phase 4
Not yet recruiting
Conditions
Mastectomy
Lymphedema
Breast Cancer
Registration Number
NCT06574022
Lead Sponsor
University of Cincinnati
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not yet recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents);Postoperative pain as indicated by postoperative opioid use discontinuation
Secondary Outcome Measures
NameTimeMethod
Post-operative pain scores indicated by patient report Numeric Rating Scale;Post-operative pain scores indicated by patient survey;Patient satisfaction indicated by patient report;Intraoperative procedure time measured as from time of incision to start of closing;Intraoperative opioid administration measured in Milliequivalents;Operating room delays measured as anesthesia start time that is greater than 1 hour after the scheduled start time;Postoperative length of stay as measured by the number of nights spent in the hospital after surgery.
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