Randomized comparative double blind prospective study with hyperbaric prilocaine 2 % and 3 different doses of sufentanil for elective caesarean section.
Phase 1
- Conditions
- Healthy pregnant womenTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2018-000016-19-BE
- Lead Sponsor
- niversitair ziekenhuis Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 60
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): - duration of sensory and motor block<br>- the (dis)comfort of the patient<br>- hemodynamics perioperatively<br>- monitoring neonatal umbilical blood gasses (including methemoglobinemia) and Apgar scores.<br><br>;Timepoint(s) of evaluation of this end point: 5 minutes after injection and every 10 minutes after externalisation until internalisation<br>