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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913573
Recruitment Status : Unknown
Verified September 2016 by Jeannie Shen, Huntington Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Jeannie Shen, 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Device: Ultrasound Drug: 0.25% bupivacaine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Post-op pain [ Time Frame: within first 48 hours ]
    post-op pain assessed by Visual Analog Scale


Secondary Outcome Measures :
  1. Post-op nausea/vomiting [ Time Frame: within first 48 hours ]
    post-op nausea/vomiting score assessed on standard scale



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913573


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

Locations
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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
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Principal Investigator: Jeannie Shen, MD Huntington Memorial Hospital
Publications of Results:

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Responsible Party: Jeannie Shen, Director, Breast Surgery, Huntington Memorial Hospital
ClinicalTrials.gov Identifier: NCT02913573    
Other Study ID Numbers: 31801/1
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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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