Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01355757 | Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery | EARLY_PHASE1 | COMPLETED | 70 | — | — | Jun 1, 2011 | Jan 1, 2013 | May 19, 2014 | 1 | United States |
To describe rehabilitation achievement and quality of life during 24-week follow-up after shoulder arthroscopy and rotator cuff repair, and identify any association between type of anesthesia procedure and patients' quality of life
| Arm | Type | Description |
|---|---|---|
| Baxter INFUSOR System | EXPERIMENTAL | Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia |
| Single Injection of Local Anesthetic | ACTIVE_COMPARATOR | Single injection of 20 ml ropivacaine 0.5% |
| Name | Type | Description |
|---|---|---|
| Baxter INFUSOR System | DEVICE | Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia |
| Single Injection of Local Anesthetic | DRUG | Single injection of 20 ml ropivacaine 0.5% |
Inclusion Criteria: Patients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form. Inclusive criteria are: * 18-75 years of age * ASA physical status I-III * BMI \< 35 kg/m2 Exclusion Criteria: * all open shoulder procedures * patient having diffic...