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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Huntington Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Jeannie Shen, Huntington Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02913573
First received: September 19, 2016
Last updated: September 22, 2016
Last verified: September 2016

September 19, 2016
September 22, 2016
September 2016
September 2018   (final data collection date for primary outcome measure)
Post-op pain [ Time Frame: within first 48 hours ] [ Designated as safety issue: No ]
post-op pain assessed by Visual Analog Scale
Same as current
No Changes Posted
Post-op nausea/vomiting [ Time Frame: within first 48 hours ] [ Designated as safety issue: No ]
post-op nausea/vomiting score assessed on standard scale
Same as current
Not Provided
Not Provided
 
Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction
Pectoral Nerve Block vs. Standard Anesthesia in Patients Undergoing Mastectomy and Immediate Breast Reconstruction: Impact on Post-operative Pain and Nausea/Vomiting
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasm
  • Device: Ultrasound
    Pectoral nerve block is a regional block administered under ultrasound guidance which blocks the nerves of the thorax and chest areas.
  • Drug: 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.
    Other Name: 0.25% Marcaine
  • 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.
    Interventions:
    • Device: Ultrasound
    • Drug: 0.25% bupivacaine
  • No Intervention: GA only
    Patients will receive standard general anesthesia.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2019
September 2018   (final data collection date for primary outcome measure)

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
Female
18 Years to 85 Years   (Adult, Senior)
No
Contact: Jeannie Shen, MD (626) 356-3167 jeannie@jeannieshenmd.com
Contact: Denise Pitt, JD (626) 397-3674 denise.pitt@huntingtonhospital.com
United States
 
NCT02913573
31801/1
Yes
No
Not Provided
Jeannie Shen, Huntington Memorial Hospital
Huntington Memorial Hospital
Not Provided
Principal Investigator: Jeannie Shen, MD Huntington Memorial Hospital
Huntington Memorial Hospital
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP