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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pectoral Nerve Block vs. Standard Anesthesia in Patients Undergoing Mastectomy and Immediate Breast Reconstruction: Impact on Post-operative Pain and Nausea/Vomiting

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Device: Ultrasound
* Drug: 0.25% bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GA + Pec Block<br>Following induction of general anesthesia, the patients in the intervention group will undergo an ultrasound-guided pectoral block. With the patient in proper position, the infraclavicular and axillary regions are prepped with chlorhexidine. An US probe is placed below the third of the clavicle over the pectoralis major muscle. After identifying the appropriate anatomical structures, a 21-gauge echogenic needle is advanced under US visualization to the tissue plane between the pectoral major and pectoral minor muscles where the lateral and medial pectoralis nerves lie and 15 mL of 0.25% bupivacaine will be deposited. 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. | Device: Ultrasound<br>* Pectoral nerve block is a regional block administered under ultrasound guidance which blocks the nerves of the thorax and chest areas.<br>Drug: 0.25% bupivacaine<br>* 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.<br>* Other names: 0.25% Marcaine;|
| No Intervention: GA only<br>Patients will receive standard general anesthesia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op pain | post-op pain assessed by Visual Analog Scale | within first 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op nausea/vomiting | post-op nausea/vomiting score assessed on standard scale | within first 48 hours |