Other Acute Postoperative Pain Clinical Trial
Official title:
Is PECS Block Equivalent to Paravertebral Block in Preventing Postoperative Pain After Breast Surgery? A Randomized, Controlled, Double-blind, Multicenter Trial
Two regional anesthesia techniques already in use in common clinical practice -paravertebral block and pectoral nerve block (PECS block) are compared in a randomized, double-blind, multicenter, controlled, non-inferiority trial, in order to compare their success rate in patients udergoing breast surgery.
Status | Recruiting |
Enrollment | 86 |
Est. completion date | September 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adult patients - ASA class 1 to 3 patients - patients scheduled for elective breast mastectomy or quadrantectomy Exclusion Criteria: - patients' refusal - contraindication to regional anaesthesia (coagulopathies, concurrent anticoagulant therapy, allergy to local anaesthetics, infection at puncture site) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Ospedale Regionale di Bellinzona e Valli | Bellinzona |
Lead Sponsor | Collaborator |
---|---|
Ospedale Regionale Bellinzona e Valli |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success rate (measured via visual analogue scale) | Changes in postoperative pain level of intensity over time will be measured via visual analogue scale (on a 0 to 100 scale, where 0 means no pain and 100 stands for the maximum pain ever experienced). Patients in both groups will be asked to rate their postoperative pain levels at fixed intervals, i.e. in the postoperative anesthesia care unit and once in the ward at 6, 12, 24 hours after surgery | 24 hours after surgery | |
Secondary | Safety (incidence of complications) | Safety will be assessed as incidence of complications in the two groups over the first 24hours. Complications monitored will be: clinical signs of pneumothorax, inadvertent vascular puncture, local anesthetic toxicity | 24 hours after surgery | |
Secondary | Patients' satisfaction (subjective perception of the experience on a 0 to 100 scale) | Patients will be asked to rate their satisfaction with regard to procedural pain and subjective perception of the experience on a 0 to 100 scale | 24 hours after surgery |
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