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OpenTrials
Completed

NCT Number: NCT04016376

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

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.

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Key information

Conditions

Breast Cancer Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

Primary outcomes

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

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2019
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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