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

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ClinicalTrials.gov Identifier: NCT04016376
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Cancer Female Drug: PVB Protocol Drug: PECS-1 Drug: Serratus Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PVB
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
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.

Experimental: PVB + PECS-1

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
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: 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

Experimental: Serratus + 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.

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
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: 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.




Primary Outcome Measures :
  1. Compare preoperative nerve blocks between a combination of nerve blocks and PVB alone to decrease postoperative opioid consumption [ Time Frame: 30 days from study treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016376


Contacts
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Contact: Hanae Tokita, MD 212-639-3043 tokitah@mskcc.org
Contact: Emily Lin, MD 646-888-7170 line@mskcc.org

Locations
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United States, New York
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Hanae Tokita, MD    212-639-3043      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Hanae Tokita, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04016376     History of Changes
Other Study ID Numbers: 19-238
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
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

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs