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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
  Purpose
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.

Condition Intervention Phase
Breast Neoplasm
Device: Ultrasound
Drug: 0.25% bupivacaine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pectoral Nerve Block vs. Standard Anesthesia in Patients Undergoing Mastectomy and Immediate Breast Reconstruction: Impact on Post-operative Pain and Nausea/Vomiting

Resource links provided by NLM:


Further study details as provided by Huntington Memorial Hospital:

Primary Outcome Measures:
  • Post-op pain [ Time Frame: within first 48 hours ] [ Designated as safety issue: No ]
    post-op pain assessed by Visual Analog Scale


Secondary Outcome Measures:
  • Post-op nausea/vomiting [ Time Frame: within first 48 hours ] [ Designated as safety issue: No ]
    post-op nausea/vomiting score assessed on standard scale


Estimated Enrollment: 60
Study Start Date: September 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: GA only
Patients will receive standard general anesthesia.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02913573

Contacts
Contact: Jeannie Shen, MD (626) 356-3167 jeannie@jeannieshenmd.com
Contact: Denise Pitt, JD (626) 397-3674 denise.pitt@huntingtonhospital.com

Locations
United States, California
Huntington Memorial Hospital Recruiting
Pasadena, California, United States, 91105
Contact: Denise Pitt, JD    626-397-3764    denise.pitt@huntingtonhospital.com   
Sponsors and Collaborators
Huntington Memorial Hospital
Investigators
Principal Investigator: Jeannie Shen, MD Huntington Memorial Hospital
  More Information

Publications:

Responsible Party: Jeannie Shen, Director, Breast Surgery, Huntington Memorial Hospital
ClinicalTrials.gov Identifier: NCT02913573     History of Changes
Other Study ID Numbers: 31801/1 
Study First Received: September 19, 2016
Last Updated: September 22, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2016