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

NCT03183596 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: F000000000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Deep Serratus Block; Reconstructive Breast Surgery; Superficial Serratus block

Outcome Measures

Primary Outcomes (1)

• Total Pain Score

  Collection of pain scores (VAS) until approximately 48 hours post-operatively

  baseline to 48 hrs postoperatively

Secondary Outcomes (3)

• Average Opioid consumption

  48 hrs postoperatively

• Length of Stay

  baseline to 72 hrs post-operatively

• PONV Medications

  baseline to 48 hrs post-operatively

Study Arms (2)

Deep Serratus Anterior Block

ACTIVE COMPARATOR

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; Drug: Dexamethasone

Superficial Serratus Anterior Block

ACTIVE COMPARATOR

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; Drug: Dexamethasone

Interventions

Bupivacaine DRUG

20-60cc of 0.25% Bupivacaine

Also known as: Marcaine, Sensorcaine

Deep Serratus Anterior Block; Superficial Serratus Anterior Block

Dexamethasone DRUG

2-4mg of Dexamethasone

Also known as: Ozurdex, Decadron, DexPak, Maxidex, Baycadron

Deep Serratus Anterior Block; Superficial Serratus Anterior Block

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing reconstructive breast surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Christopher Godlewski, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 12, 2017
• Study Start: December 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: January 1, 2024
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)