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

Phase 3

Withdrawn

• Conditions: Pain, Postoperative
• Interventions: Drug: Bupivacaine; Drug: Dexamethasone

• Registration Number: NCT03183596
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31
• Study Start: 2019-12
• Primary Completion: 2020-08
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients undergoing reconstructive breast surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Superficial Serratus Anterior Block	Bupivacaine	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.
Deep Serratus Anterior Block	Bupivacaine	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.
Deep Serratus Anterior Block	Dexamethasone	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.
Superficial Serratus Anterior Block	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Total Pain Score	baseline to 48 hrs postoperatively	Collection of pain scores (VAS) until approximately 48 hours post-operatively

Secondary Outcome Measures

Name	Time	Method
Average Opioid consumption	48 hrs postoperatively	Average opioid consumption 48hrs postoperatively between study group and control
Length of Stay	baseline to 72 hrs post-operatively	Number of days in the hospital
PONV Medications	baseline to 48 hrs post-operatively	Mean time onset use of rescue PONV medications postoperatively

Trial Locations

Locations (1)

UAB Department of Anesthesiology and Perioperative Medicine; 🇺🇸 Birmingham, Alabama, United States