Back to results

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

Primary Purpose

Pain, Postoperative

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine

Dexamethasone

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Deep Serratus Block, Reconstructive Breast Surgery, Superficial Serratus block

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UAB Department of Anesthesiology and Perioperative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Deep Serratus Anterior Block

Superficial Serratus Anterior Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total Pain Score

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

Secondary Outcome Measures

Average Opioid consumption

Average opioid consumption 48hrs postoperatively between study group and control

Length of Stay

Number of days in the hospital

PONV Medications

Mean time onset use of rescue PONV medications postoperatively

Full Information

NCT ID

NCT03183596

First Posted

June 7, 2017

Last Updated

May 29, 2018

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03183596

Brief Title

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

Official Title

Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery (Randomized, Pilot Study)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Principal investigator determination

Study Start Date

December 2019 (Anticipated)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Pain, Postoperative

Keywords

Deep Serratus Block, Reconstructive Breast Surgery, Superficial Serratus block

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Deep Serratus Anterior Block

Arm Type

Active Comparator

Arm Description

Arm Title

Superficial Serratus Anterior Block

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Marcaine, Sensorcaine

Intervention Description

20-60cc of 0.25% Bupivacaine

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Ozurdex, Decadron, DexPak, Maxidex, Baycadron

Intervention Description

2-4mg of Dexamethasone

Primary Outcome Measure Information:

Title

Total Pain Score

Description

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

Time Frame

baseline to 48 hrs postoperatively

Secondary Outcome Measure Information:

Title

Average Opioid consumption

Description

Average opioid consumption 48hrs postoperatively between study group and control

Time Frame

48 hrs postoperatively

Title

Length of Stay

Description

Number of days in the hospital

Time Frame

baseline to 72 hrs post-operatively

Title

PONV Medications

Description

Mean time onset use of rescue PONV medications postoperatively

Time Frame

baseline to 48 hrs post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Godlewski, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAB Department of Anesthesiology and Perioperative Medicine

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs