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Double Blind Randomized Phase III Controlled Trial Comparing the Effect of Intraperitoneal Nebulization of Ropivacaine With Intraperitoneal Instillation of Ropivacaine on Pain Control After Laparoscopic Cholecystectomy
Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after laparoscopic cholecystectomy.
Details
| Lead sponsor | San Gerardo Hospital |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2008-04 |
| Completion | 2009-05 |
Conditions
- Laparoscopic Cholecystectomy
Interventions
- Ropivacaine 60 mg
- Ropivacaine 100 mg
Primary outcomes
- Postoperative Pain — 48 hours
Postoperative pain was assessed by Visual analgue scale (VAS 0 to 100 points) at rest (static VAS) and after a deep inspiration or cough (dynamic VAS). The proportion of patients with adequate pain control after surgery (dynamic VAS \< 3) will also be assessed.
Countries
Italy