Opioid Use Clinical Trial
Official title:
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.
Verified date | November 2021 |
Source | AUSL Romagna Rimini |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | November 15, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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, - BMI =40 - allergies and / or contraindications to the administration of the drugs used in the study, - use of chronic opioid therapy |
Country | Name | City | State |
---|---|---|---|
Italy | Domenico Pietro Santonastaso | Cesena | Emilia Romagna |
Lead Sponsor | Collaborator |
---|---|
AUSL Romagna Rimini |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative pain assessment | post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain) | 12 hours | |
Secondary | Length of hospital stay | The number of days of hospitalization after surgery will be assessed | 3 days | |
Secondary | Evaluate the incidence and severity of persistent pain 6 months after surgery | Evaluate the incidence and severity of persistent pain 6 months after surgery using Numeric rating scale (from 0, no pain, to 10, worst pain) | six months | |
Secondary | Opioid use | Intra and post-operative opioid use | 36 hours | |
Secondary | Incidence of PONV | Incidence of post operative nausea and vomiting (PONV) in the first 36 hours | 36 hours | |
Secondary | Assessment of patient satisfaction with the anesthesiological technique | Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates "entirely dissatisfied" and 5 indi- cates "very satisfied" | 36 hours |
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