Recruiting
Phase 2

Pectoral Nerve Block

Sponsor:

Huntington Memorial Hospital

Code:

NCT02913573

Conditions

Breast Neoplasm

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ultrasound

0.25% bupivacaine

Study Details

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.

Conditions

Breast Neoplasm

Study ID

NCT02913573

Start date

Sep, 2016

Status verified date

Sep, 2016

Completion date

Mar, 2019

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GA + Pec Block

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.

no intervention: GA only

Patients will receive standard general anesthesia.

Interventions

Ultrasound

Pectoral nerve block is a regional block administered under ultrasound guidance which blocks the nerves of the thorax and chest areas.

0.25% bupivacaine

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.

Primary outcome measure

  • Post-op pain [ Time Frame: within first 48 hours ]

Central Contacts and Locations

Central contacts

Jeannie Shen, MD

(626) 356-3167jeannie@jeannieshenmd.com

Denise Pitt, JD

(626) 397-3674denise.pitt@huntingtonhospital.com

Locations

Huntington Memorial Hospital

Recruiting

Pasadena, California, United States, 91105

Contacts

Denise Pitt, JD

626-397-3764denise.pitt@huntingtonhospital.com

More Information

Sponsor

Huntington Memorial Hospital

Last update posted

Sep 23, 2016

Last verified

Sep, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Huntington Memorial Hospital on 2016-09-23.