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Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery

NCT ID: NCT03183596

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2024-01-31

Brief Summary

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The novel introduction of various chest wall blocks such as the Pecs I and II/modified Pecs blocks as well as the Serratus Anterior Plane Block have extended the application of perioperative regional anesthesia to provide analgesia for breast surgery. However, to our knowledge, there are no large studies that truly delineate the optimal injection site for the Serratus Anterior Plane Block.

Detailed Description

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Analgesia for reconstructive breast surgery can be a challenging undertaking; these women have often been through painful mastectomy procedures coupled with the mental and physical discomfort of chemotherapy and its attendant side effects. Additionally, the surgery itself can provoke significant pain; often requiring extensive dissection of soft tissue and muscle to provide flap coverage as well the real discomfort of tissue expansion. The literature has described 2 possible injection sites for the Serratus Anterior Block, however, no study has defined optimal location based on analgesia and duration. Patients will be randomized to receive a "deep" Serratus Anterior Block (DSAB) where local anesthetic is deposited deep to the serratus or a "superficial" Serratus Anterior Block (SSAB) where the local anesthetic is placed between serratus and latissimus dorsi. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting.

Conditions

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Pain, Postoperative

Keywords

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Deep Serratus Block Reconstructive Breast Surgery Superficial Serratus block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There has been no large, randomized study to define optimal location of injection based on analgesia and duration. Patients will be randomized to receive a "deep" Serratus Anterior Block (DSAB) where local anesthetic is deposited deep to the serratus or a "superficial" Serratus Anterior Block (SSAB) where the local anesthetic is placed between serratus and latissimus dorsi.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Deep Serratus Anterior Block

Patients in the "deep" Serratus Anterior Block (DSAB) group will have 20-60cc of 0.25% bupivacaine and 2-4mg of dexamethasone deposited deep to the serratus. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

20-60cc of 0.25% Bupivacaine

Dexamethasone

Intervention Type DRUG

2-4mg of Dexamethasone

Superficial Serratus Anterior Block

Patients in the "superficial" Serratus Anterior Block (SSAB) group will have 20-60cc of 0.25% bupivacaine and 2-4mg of dexamethasone placed between serratus and latissimus dorsi. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

20-60cc of 0.25% Bupivacaine

Dexamethasone

Intervention Type DRUG

2-4mg of Dexamethasone

Interventions

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Bupivacaine

20-60cc of 0.25% Bupivacaine

Intervention Type DRUG

Dexamethasone

2-4mg of Dexamethasone

Intervention Type DRUG

Other Intervention Names

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Marcaine, Sensorcaine Ozurdex, Decadron, DexPak, Maxidex, Baycadron

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing reconstructive breast surgery

Exclusion Criteria

* Patients with allergies to the local anesthetic
* Patients who do no consent to regional anesthesia
* Patients in which serratus block would be contraindicated
* Patients whose anatomy preclude placement of the block
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Christopher Godlewski

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Godlewski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F000000000

Identifier Type: -

Identifier Source: org_study_id