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

Primary Purpose

Breast Cancer, Breast Cancer Female

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PVB Protocol
PECS-1
Serratus
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PVB

PVB + PECS-1

Serratus + PECS-1

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 9, 2019
Last Updated
June 8, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04016376
Brief Title
Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVB
Arm Type
Experimental
Arm 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.
Arm Title
PVB + PECS-1
Arm Type
Experimental
Arm 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.
Arm Title
Serratus + PECS-1
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PVB Protocol
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
PECS-1
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Serratus
Intervention Description
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanae Tokita, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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

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