Serratus Anterior Plane Block in Patients Undergoing Mastectomy

Completed · Phase 4

Conditions studied: Pain, Post-operative

In brief

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.

Key facts

Study ID

NCT03154658

Run by

University of Texas Southwestern Medical Center

People needed

66

Starts

2017-04-01

Expected to finish

2020-03-01

Last updated by the study team

2021-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients 18 years or older
• Individuals undergoing either a mastectomy or mastectomy with tissue expander for which the anesthetic plan includes a serratus anterior plane block.

You may not qualify if…

• Any known sensory deficit of the anterolateral chest wall.
• Any local disorder of the skin or otherwise where blockade is to be performed which would prevent safe performance of the block
• Pregnancy
• American Society of Anesthesiology classification greater than 3
• Allergy to amide local anesthetic medications
• Chronic pain conditions
• Preoperative opioid use greater than 20 oral morphine equivalents per day
• Any coagulation abnormality which would be a contraindication for block placement
• Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
• Body mass index >50
• Incarceration
• Inability to understand study procedures including inability to understand the English language
• Inability to provide adequate informed consent
• Refusal to participate in the study

Where it is running

• University of Texas Southwestern Medical Centers — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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