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NCT04016376 Clinical Trial

Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction

Breast Cancer Clinical Trial

Official title:
Cluster-Randomized, Prospective Assessment of Postoperative Pain Management in Patients Undergoing Bilateral Mastectomy With Immediate Reconstruction With Tissue Expander (BMWRw/TE) Using Preoperative Paravertebral (PVB), Serratus+PECS-1, or PVB+PECS-1 Nerve Blocks

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04016376
Other study ID # 19-238
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date July 5, 2019
Est. completion date July 2025

Study information
Verified date June 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with immediate reconstruction with tissue expanders reduce the need for pain medication after surgery.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1507
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Female patients >/= 18 years old - Undergoing Bilateral Mastectomy with immediate reconstruction (BMw/IR) - Scheduled for surgery at Josie Robertson Surgical Center (JRSC) - Must be appropriate for an agree to receive a nerve block - Must be appropriate for randomization - Able to read and speak English - Willing and able to provide written informed consent Exclusion Criteria: - None applicable, as exclusion occurs prior to consent

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PVB Protocol
Patient will be placed in the prone, lateral, or sitting position. With an ultrasound probe placed in the parasagittal or transverse position, the paravertebral space will be identified. Injections will be done in an in-plane manner relative to the ultrasound probe. Local anesthesia will be injected to cover T1-T6 dermatomes.
• PECS-1
For PECS-1, the patient will be placed in the supine position with an ultrasound probe placed inferolaterally starting at the mid-clavicular level the pectoralis major and minor will be identified. Injection of local anesthesia will be performed between the pectoralis major and minor
• Serratus
For the serratus block, the patient will be placed in the supine or lateral decubitus position and with an ultrasound probe, in the parasagittal plane, the serratus muscles will be identified. Injections will be done in-plane below the serratus anterior.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare preoperative nerve blocks between a combination of nerve blocks and PVB alone to decrease postoperative opioid consumption 30 days from study treatment
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