Phase 2
N=40
Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
Pregnant Women
Bottom Line
View on ClinicalTrials.gov: NCT03036384 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Success of Anesthesia — 4; 4; 4; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HB Prilocaine 2% (varying dose) (Drug); HB Prilocaine 2% (Drug); Sufentanil (Drug); Morphine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success of Anesthesia |
4; 4; 4; 1; 4; 4 | — |
| SECONDARY Sensitive Block Duration |
2.31; 3.25 | — |
| SECONDARY Sensitive Block at End of Surgery |
3.88; 3.00 | — |
| SECONDARY Motor Block Duration |
2.75; 3.50 | — |
| SECONDARY Bromage Motor Block Level at End of Surgery |
3.56; 4.00 | — |
| SECONDARY Newborn Apgar Score |
8.47; 9.00; 9.63; 9.75; 9.84; 10 | — |
| SECONDARY Newborn Methemoglobinemia (MetHb) |
1.59; 1.60 | — |
| SECONDARY Number of Participants Needing Vasopressors |
15; 2 | — |
| SECONDARY Number of Participants With Transient Neurologic Symptoms (TNS) |
0; 0 | — |
| SECONDARY Number of Participants With Nausea or Vomiting |
3; 0 | — |
| SECONDARY Number of Participants With Pruritus |
0; 0 | — |
| SECONDARY Number of Participants With Urinary Retention |
0; 0 | — |
| SECONDARY Number of Participants With Dizziness |
5; 2 | — |
| SECONDARY Number of Satisfied Participants |
16; 4 | — |
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)
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists physical status (ASA) 37 SA
- Elective cesarean delivery
- Singleton pregnancy
- Non complicated pregnancy
- Signed informed consent obtained prior to any study specific assessments and procedures
Exclusion Criteria
- Twin pregnancy
- History of 2 cesarean section or more
- Diabetes and gestational diabetes
- Placenta praevia
- Congenital foetal abnormality
- Patient in labour
- Membrane rupture
- Known allergy to local anaesthetics
- Disagreement of the patient
- Pregnancy-induced hypertension
- Pre eclampsia and eclampsia
Data sourced from ClinicalTrials.gov (NCT03036384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.