Healthy pregnant women
Conditions
Interventions
Trade Name: Tachipri
Product Name: Prilocaine hydrochloride
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PRILOCAINE
CAS Number: 721-50-6
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Universitair ziekenhuis Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - gender: female - age: 18-45 years - American Society of Anesthesiologists physical status I - II - indication for elective caesarean delivery of uncomplicated singleton pregnancy at term ( 37 weeks or more) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - ever had an allergic reaction to a local anaesthetic in the past - signs of skin infection or inflammation at or near the proposed site of the injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to determine the ideal dose of spinal sufentanil in elective caesarean delivery;Secondary Objective: N/A;Primary end point(s): The primary end point is the VAS score during internalization of the uterus, the most painful event during caesarean delivery;Timepoint(s) of evaluation of this end point: internalization of the uterus | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - duration of sensory and motor block - the (dis)comfort of the patient - hemodynamics perioperatively - monitoring neonatal umbilical blood gasses (including methemoglobinemia) and Apgar scores. ;Timepoint(s) of evaluation of this end point: 5 minutes after injection and every 10 minutes after externalisation until internalisation | — |
Countries
Belgium
Contacts
Public ContactStudycoordinator
Universitair ziekenhuis Brussel
Outcome results
None listed