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GA + Pec Block for Breast Cancer

Phase 2
Waitlist Available
Led By Jeannie Shen, MD
Research Sponsored by Huntington Memorial Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within first 48 hours
Awards & highlights

Study 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.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within first 48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and within first 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-op pain
Secondary outcome measures
Nausea

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GA + Pec BlockExperimental Treatment2 Interventions
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.
Group II: GA onlyActive Control1 Intervention
Patients will receive standard general anesthesia.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~1950
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Huntington Memorial HospitalLead Sponsor
5 Previous Clinical Trials
1,797 Total Patients Enrolled
1 Trials studying Breast Cancer
64 Patients Enrolled for Breast Cancer
Jeannie Shen, MDPrincipal InvestigatorHuntington Memorial Hospital
1 Previous Clinical Trials
64 Total Patients Enrolled
1 Trials studying Breast Cancer
64 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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~7 spots leftby Apr 2025