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

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ClinicalTrials.gov Identifier: NCT03183596
Recruitment Status : Withdrawn (Principal investigator determination)
First Posted : June 12, 2017
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Godlewski, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Bupivacaine Drug: Dexamethasone Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery (Randomized, Pilot Study)
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
Active Comparator: 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.
Drug: Bupivacaine
20-60cc of 0.25% Bupivacaine
Other Name: Marcaine, Sensorcaine

Drug: Dexamethasone
2-4mg of Dexamethasone
Other Name: Ozurdex, Decadron, DexPak, Maxidex, Baycadron

Active Comparator: 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.
Drug: Bupivacaine
20-60cc of 0.25% Bupivacaine
Other Name: Marcaine, Sensorcaine

Drug: Dexamethasone
2-4mg of Dexamethasone
Other Name: Ozurdex, Decadron, DexPak, Maxidex, Baycadron




Primary Outcome Measures :
  1. Total Pain Score [ Time Frame: baseline to 48 hrs postoperatively ]
    Collection of pain scores (VAS) until approximately 48 hours post-operatively


Secondary Outcome Measures :
  1. Average Opioid consumption [ Time Frame: 48 hrs postoperatively ]
    Average opioid consumption 48hrs postoperatively between study group and control

  2. Length of Stay [ Time Frame: baseline to 72 hrs post-operatively ]
    Number of days in the hospital

  3. PONV Medications [ Time Frame: baseline to 48 hrs post-operatively ]
    Mean time onset use of rescue PONV medications postoperatively



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03183596


Locations
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United States, Alabama
UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Christopher Godlewski, MD University of Alabama at Birmingham

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Responsible Party: Christopher Godlewski, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03183596     History of Changes
Other Study ID Numbers: F000000000
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Christopher Godlewski, University of Alabama at Birmingham:
Deep Serratus Block
Reconstructive Breast Surgery
Superficial Serratus block
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents