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Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery
Because local anesthetic infiltration has not been comparated to continuous infusion after spine fusion surgery, the investigators designed this study to determine whether this technique could enhance analgesia and improve patient outcome after posterior lumbar arthrodesis. The Main Objective of the study is to compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an infiltration "single shot" of local analgesic (Ropivacaïne), one receiving a single shot infiltration and a continuous infiltration of Ropivacaine during 48 hours. In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL, and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h. The secondary outcomes are the consumption of morphine,the rate of the nausea and the postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration of hospital stay and the persistence of residual pain.
Details
| Lead sponsor | Centre Hospitalier Universitaire de Nice |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 60 |
| Start date | 2008-12 |
| Completion | 2011-03 |
Conditions
- Postoperative Pain
Interventions
- Ropivacaine
Primary outcomes
- Primary end points Principal: We compare the pain between 2 groups by means of the EVA (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16, H24, H48. — 2 days
Countries
France