Serratus Anterior Muscle Plane Block vsThoracic Paravertebral Block For Unilateral Mastectomies

• Status: Withdrawn
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Memorial Hermann Hospital
• Treatments: Bupivacaine; Lidocaine

Criteria

Inclusion Criteria:

• Simple or radical unilateral mastectomy with or without axillary lymph node dissection.

• American Society of Anesthesia (ASA) I, II and III

Exclusion Criteria:

• 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