Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction

• Status: Unknown status
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huntington Memorial Hospital
• Treatments: Bupivacaine

Criteria

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