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

Phase 2

• Conditions: Breast Neoplasm
• Interventions: Device: Ultrasound; Drug: 0.25% bupivacaine

• Registration Number: NCT02913573
• Lead Sponsor: Huntington Memorial Hospital

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.

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Study First Posted: 2016-09-23
• Last Update Posted: 2016-09-23
• Primary Completion: 2018-09
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GA + Pec Block	Ultrasound	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.
GA + Pec Block	0.25% bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Post-op pain	within first 48 hours	post-op pain assessed by Visual Analog Scale

Secondary Outcome Measures

Name	Time	Method
Post-op nausea/vomiting	within first 48 hours	post-op nausea/vomiting score assessed on standard scale

Trial Locations

Locations (1)

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States