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

NCT04016376 | Completed Phase 4 FDA Drug

• 1 other identifier: 19-238
• Study Type: interventional
• Target: 1,507
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Cancer Female

Keywords

Mastectomy; Double Mastectomy; Mastectomy with reconstruction; Double mastectomy with reconstruction; Double mastectomy with immediate reconstruction; Mastectomy with immediate reconstruction; Memorial Sloan Kettering Cancer Center; 19-238

Outcome Measures

Primary Outcomes (1)

• Compare preoperative nerve blocks between a combination of nerve blocks and PVB alone to decrease postoperative opioid consumption

  2 days

Study Arms (3)

PVB

EXPERIMENTAL

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.

Drug: PVB Protocol

PVB + PECS-1

EXPERIMENTAL

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.

Drug: PVB Protocol; Drug: PECS-1

Serratus + PECS-1

EXPERIMENTAL

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.

Drug: PECS-1; Drug: Serratus

Interventions

PVB Protocol DRUG

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.

PVB; PVB + PECS-1

PECS-1 DRUG

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

PVB + PECS-1; Serratus + PECS-1

Serratus DRUG

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.

Serratus + PECS-1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Tokita HK, Assel MJ, Serafin J, Lin E, Sarraf L, Masson G, Nelson JA, Moo TA, McCready T, Vakassi C, Hingula L, Jackson J, Horine S, Baqai-Stern A, Lewis A, Nadav D, Teng H, Kim J, Hagen J, Scanlon M, Puttanniah V, Legler A, Gauran C, Simon BA, Vickers A. Paravertebral or Serratus Anterior Plane Block Combined with Interpectoral Blocks versus Paravertebral Block for Mastectomy: A Cluster-randomized Trial of 1,507 Patients. Anesthesiology. 2026 Feb 1;144(2):379-389. doi: 10.1097/ALN.0000000000005842. Epub 2025 Nov 10.

  PMID: 41212546 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PVB protocol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hanae Tokita, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to 1 of 3 groups (approximately n=500 patients per group) of standard of care preoperative nerve blocks consisting of either: i) PVB, ii) serratus+PECS-1, or iii) PVB+PECS-1. Each group will receive ropivacaine or bupivacaine +/- clonidine (0.5 - 1 mcg/kg not to exceed a total of 100 mcg) +/- dexamethasone (up to 4 mg) in one of three routine nerve block approaches prior to surgical procedure as is current standard of care.

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 11, 2019
• Study Start: July 5, 2019
• Primary Completion: February 25, 2026
• Study Completion: February 25, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)