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Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery : a Dose-finding Study Bases on the Continual Reassessment Method (CRM)
Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly used for spinal injection in cesarean section. Nevertheless, its use often results in a long duration of motor nerve block and a haemodynamical instability. Recently developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the effect of the local anesthetics while decreasing their dose-related side effects, the aim of this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)
Details
| Lead sponsor | Centre Hospitalier Universitaire Saint Pierre |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2016-03 |
| Completion | 2016-11 |
Conditions
- Pregnant Women
Interventions
- HB Prilocaine 2% (varying dose)
- HB Prilocaine 2%
- Sufentanil
- Morphine
Primary outcomes
- Success of Anesthesia — during surgery (average 1 hour)
The nerve blockade will be considered as success when a bilateral T4 level will reach in 15 minutes after intrathecal injection without additional epidural injection needed within 45 minutes peri-operative ; no pain at the skin incision, no pain during 45 minutes after the skin incision
Countries
Belgium