Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
University of Cincinnati
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.
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 indic…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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-Englis…
Interventions
- DrugBupivacain
Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 30 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.
- DrugExparel
Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 20 cc of Exparel mixed with 10 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.
- ProcedureIntraoperative Pecs II block (IOB) & superior AT (EX or BP)
Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle with superior anesthetic as determined by stage I, after mastectomy completion and prior to reconstruction, if performed, or wound closure.
- ProcedurePreoperative Pecs II block (POB) & superior AT (EX or BP)
Preoperative Pecs II block to be administered by 1 of 6 acute pain specialized anesthesiologists in same day surgery. Patient will be lightly sedated with midazolam, at the discretion of the anesthesiologist. The pecs II block will be performed under ultrasound guidance using a 21-gauge, 80 mm length needle to administer the superior anesthetic as determined in stage I.
Location
- University of Cincinnati Medical CenterCincinnati, Ohio