Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
Summary
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)
Timeline
- Start
- 2016-03
- Primary completion
- 2016-11
- Completion
- 2016-11
Publications
- Background Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.
- Background Gupta PK, Chevret S, Zohar S, Hopkins PM. What is the ED95 of prilocaine for femoral nerve block using ultrasound? Br J Anaesth. 2013 May;110(5):831-6. doi: 10.1093/bja/aes503. Epub 2013 Feb 7.
- Goffard P, Vercruysse Y, Leloup R, Fils JF, Chevret S, Kapessidou Y. Determination of the ED95 of intrathecal hyperbaric prilocaine with sufentanil for scheduled cesarean delivery: a dose-finding study based on the continual reassessment method. BMC Anesthesiol. 2020 Nov 26;20(1):293. doi: 10.1186/s12871-020-01199-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | prilocaine | Small molecule | 30 mg | Intrathecal |
| Subject | prilocaine | Small molecule | 35 mg | Intrathecal |
| Subject | prilocaine | Small molecule | 40 mg | Intrathecal |
| Subject | prilocaine | Small molecule | 45 mg | Intrathecal |
| Subject | prilocaine | Small molecule | 50 mg | Intrathecal |
| Subject | prilocaine | Small molecule | 55 mg | Intrathecal |
| Background | Morphine | Other / unclassified | 100 ug | — |
| Background | Sufentanil | Other / unclassified | 2.5 ug | — |
Indications
No indication recorded.