Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction
Status unconfirmed · Phase 2
Conditions studied: Breast Neoplasm
In brief
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.
Key facts
- Study ID
- NCT02913573
- Run by
- Huntington Memorial Hospital
- People needed
- 60
- Starts
- 2016-09-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2016-09-23
Who can join
Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients age 18-90 years old
- Subjects able to read and understand the informed consent
- American Society of Anesthesiologists (ASA) physical status I and II
- 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)
You may not qualify if…
- Subjects unable to read or understand the informed consent
- ASA physical status III or IV
- Subjects with an allergy to local anesthetic
- Subjects with a medical contraindication to regional anesthetic, such as coagulopathy or local infection
- Subjects with a pre-existing submuscular implant
- Subjects scheduled to undergo mastectomy with myocutaneous flap reconstruction
- Subjects scheduled to undergo mastectomy without immediate reconstruction
- Subjects with a history of chronic pain or chronic opioid use
Where it is running
- Huntington Memorial Hospital — Pasadena, California, United States (enrolling)
Full record on ClinicalTrials.gov
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