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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 4

Conditions: Breast Cancer; Breast Cancer Female

Treatments: Drug: PECS-1; Drug: Serratus; Drug: PVB Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04016376

19-238

Details and patient eligibility

About

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.

Enrollment: 1,507 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,507 participants in 3 patient groups

PVB

Experimental group

Description:

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.

Treatment:

Drug: PVB Protocol

PVB + PECS-1

Experimental group

Description:

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. 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.

Treatment:

Drug: PVB Protocol

Drug: PECS-1

Serratus + PECS-1

Experimental group

Description:

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. 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.

Treatment:

Drug: Serratus

Drug: PECS-1