Breast Neoplasm
Conditions
Brief summary
Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block. Post-operative pain, nausea/vomiting scores will be assessed.
Detailed description
Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block after induction of general anesthesia and prior to the start of surgery. Post-operative pain scores and post-operative pain medication usage will be recorded. Post-operative nausea/vomiting scores and post-op anti-emetic medication usage will be recorded. The clinical impact of pectoral nerve block on this expanding population of patients will be determined.
Interventions
Pectoral nerve block is a regional block administered under ultrasound guidance where 15 mL of 0.25% bupivacaine is instilled between the pectoral major and pectoral minor muscles where the lateral and medial pectoralis nerves lie. In a similar manner, 20 mL of 0.25% bupivacaine will be deposited under ultrasound-guidance at the level of the third rib above the serratus anterior muscle.
DEVICEUltrasound
Pectoral nerve block is a regional block administered under ultrasound guidance which blocks the nerves of the thorax and chest areas.
Sponsors
Huntington Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients age 18-90 years old 2. Subjects able to read and understand the informed consent 3. American Society of Anesthesiologists (ASA) physical status I and II 4. Subjects scheduled to undergo unilateral or bilateral mastectomy with immediate breast reconstruction with submuscular placement of tissue expander or permanent implant under general anesthesia, including: * subjects diagnosed with breast cancer * subjects diagnosed with atypia or other high risk proliferative breast disease * subjects with a family history who are considered at high risk for breast cancer (including those with hereditary or genetic predisposition)
Exclusion criteria
1. Subjects unable to read or understand the informed consent 2. ASA physical status III or IV 3. Subjects with an allergy to local anesthetic 4. Subjects with a medical contraindication to regional anesthetic, such as coagulopathy or local infection 5. Subjects with a pre-existing submuscular implant 6. Subjects scheduled to undergo mastectomy with myocutaneous flap reconstruction 7. Subjects scheduled to undergo mastectomy without immediate reconstruction 8. Subjects with a history of chronic pain or chronic opioid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-op pain | within first 48 hours | post-op pain assessed by Visual Analog Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-op nausea/vomiting | within first 48 hours | post-op nausea/vomiting score assessed on standard scale |
Countries
United States
Contacts
Primary ContactJeannie Shen, MD
Backup ContactDenise Pitt, JD
Outcome results
None listed