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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03183596
• Other study ID #: F000000000
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 2019
• Est. completion date: January 2024

Study information

• Verified date: May 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
20-60cc of 0.25% Bupivacaine
• Dexamethasone
2-4mg of Dexamethasone

Locations

Country	Name	City	State
United States	UAB Department of Anesthesiology and Perioperative Medicine	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Pain Score	Collection of pain scores (VAS) until approximately 48 hours post-operatively	baseline to 48 hrs postoperatively
Secondary	Average Opioid consumption	Average opioid consumption 48hrs postoperatively between study group and control	48 hrs postoperatively
Secondary	Length of Stay	Number of days in the hospital	baseline to 72 hrs post-operatively
Secondary	PONV Medications	Mean time onset use of rescue PONV medications postoperatively	baseline to 48 hrs post-operatively