Recruiting
Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
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.
ClinicalTrials.gov IDNCT06574022
PhasePHASE4
Enrollment100
SponsorUniversity of Cincinnati
Age18 Years
SexALL
Conditions studied
Mastectomy; Lymphedema, Breast Cancer
About this study
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.
Interventions
- Drug: Bupivacain — 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.
- Drug: Exparel — 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.
- Procedure: Intraoperative 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.
- Procedure: Preoperative 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.
Primary outcomes
- Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents) (14 days post-operation)
- Postoperative pain as indicated by postoperative opioid use discontinuation (14 days post-operation)
Eligibility information
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 locations
- University of Cincinnati Medical Center, Cincinnati, Ohio 45219 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.