Clinical trial NCT03183596: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Deep Serratus Block
Reconstructive Breast Surgery
Superficial Serratus block
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Total Pain Score
timeFrame: baseline to 48 hrs postoperatively
Secondary outcomes:
measure: Average Opioid consumption
timeFrame: 48 hrs postoperatively
measure: Length of Stay
timeFrame: baseline to 72 hrs post-operatively
measure: PONV Medications
timeFrame: baseline to 48 hrs post-operatively
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Anesthesiology and Perioperative Medicine
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Christopher Godlewski, MD
role: PRINCIPAL_INVESTIGATOR
References: