Comparison of Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Intra and Postoperative Pain Control in Modified Radical Mastectomy: a Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Surgery
- Sponsor
- AUSL Romagna Rimini
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Post-operative pain assessment
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block versus thoracic paravertebral (TPV) block in the post-operative pain control after radical mastectomy.
Detailed Description
Primary outcome of our study is to compare the effectiveness of two regional anesthesia techniques, ESP block and TPV block, in the post-operative pain-control after radical mastectomy. We will also evaluate both intra and post-operative opioid consumption, the incidence of PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and the incidence of chronic pain 6 months after surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged between 18 and 85
- •American Society of Anesthesiologists classification I - III
- •Signature of consent to participate in the study
Exclusion Criteria
- •Coagulopathies and / or use of antiplatelet / anticoagulant drugs
- •Infections and/or lesions at the puncture site,
- •allergies and / or contraindications to the administration of the drugs used in the study,
- •use of chronic opioid therapy
Outcomes
Primary Outcomes
Post-operative pain assessment
Time Frame: 12 hours
post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)
Secondary Outcomes
- Length of hospital stay(3 days)
- Evaluate the incidence and severity of persistent pain 6 months after surgery(six months)
- Incidence of PONV(36 hours)
- Opioid use(36 hours)
- Assessment of patient satisfaction with the anesthesiological technique(36 hours)