Overview

Serratus Anterior Plane Block in Patients Undergoing Mastectomy

Status:
Completed
Trial end date:
2020-03-01
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized, interventional prospective study. Patients (n=66) undergoing mastectomies with or without tissue expander will be randomized to receive a supra-serratus or sub-serratus regional plane block prior to surgery. The main effect to be measured is total opioid consumption 24 hours after the operation. Secondary endpoints include measuring a change between pre-and post-operative pain scores, patient satisfaction of pain control during first 24 hours after the operation, presence of postoperative nausea and vomiting, duration of sleep on first postoperative night, and block performance time and length of stay, between the two treatment arms.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Treatments:
Ropivacaine
Criteria
Inclusion Criteria:

1. Adult patients 18 years or older

2. Individuals undergoing either a mastectomy or mastectomy with tissue expander for
which the anesthetic plan includes a serratus anterior plane block.

Exclusion Criteria:

1. Any known sensory deficit of the anterolateral chest wall.

2. Any local disorder of the skin or otherwise where blockade is to be performed which
would prevent safe performance of the block

3. Pregnancy

4. American Society of Anesthesiology classification greater than 3

5. Allergy to amide local anesthetic medications

6. Chronic pain conditions

7. Preoperative opioid use greater than 20 oral morphine equivalents per day

8. Any coagulation abnormality which would be a contraindication for block placement

9. Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum
creatinine greater than 1.4 mg/dL

10. Body mass index >50

11. Incarceration

12. Inability to understand study procedures including inability to understand the English
language

13. Inability to provide adequate informed consent

14. Refusal to participate in the study