Serratus Anterior Muscle Plane Block vsThoracic Paravertebral Block For Unilateral Mastectomies
Withdrawn before enrolling · Phase 4
Conditions studied: Breast Cancer, Mastectomy, Regional Anesthesia, Post Operative Pain
In brief
HYPOTHESIS Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block (PVB) for acute pain control after unilateral mastectomies. SPECIFIC AIMS Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in patients undergoing unilateral mastectomy Secondary aim To compare the onset and duration of block and dermatomes blocked in both groups To compare the need of post-operative rescue analgesia in both groups. To compare the development of chronic incisional pain in both groups Functional outcome with respect to daily activities.
Key facts
- Study ID
- NCT02822196
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 0
- Starts
- 2018-12-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-09-16
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Simple or radical unilateral mastectomy with or without axillary lymph node dissection.
- American Society of Anesthesia (ASA) I, II and III
You may not qualify if…
- Morbid obesity (body mass index > 40 kg/m2);
- Renal insufficiency (creatinine > 2.0 mg/DL),
- Current chronic analgesic therapy (daily use > 4 weeks),
- History of opioid dependence, pregnancy.
- Allergy to local anesthetic
- Rash/infection at the area of injection
- Coagulation disorder
- Patients on anticoagulation
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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