Efficacy and blood concentrations of epidural hydromorphone (strong opioid) in labour

Phase 1

Conditions: abour pain
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-000903-10-FI

Lead Sponsor: Oulu University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

healthy primipara
age 18-45 years
normal fullterm bregnancy
wish for epidural pain relief
no contraindications to epidural or hyrdomorphone
no regular opioid-treatment
no opioids during last 12 hours

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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

immediate need for pain relief
sleep apnea or lung dysfunction
BMI > 35 kg/m2
organ dysfunction
alcohol abuse
MAO-inhibitor use
elevated intracranial pressue
hydromorphone allergy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to improve treatment of labour pain. Study the pharmacodynamics of epidural hydromorphone bolus according to blood concentrations. ;Secondary Objective: Effect and duration of single dose hydromorphone<br>side-effects<br>neurologic and adaptive capacity scoring system for evaluating new born babies (NACS-evaluation);Primary end point(s): blood concentration of hydromorphone from mother during the labour and from umpilical vein and artery after birth;Timepoint(s) of evaluation of this end point: from mother: 0, 15, 30, 45, 60 min, 2h, 3h, 4h and then every 2 hours until birth<br>after umbilical cord cutting blood exam from umbilical vein and artery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Effect and duration of single dose hydromorphone<br>side-effects<br>neurologic and adaptive capacity scoring system for evaluating new born babies (NACS-evaluation);Timepoint(s) of evaluation of this end point: pain NRS: before epidural hydromorphone, and afterward every 15 minutes (rest and contraction pain)<br>nausea NRS every 15 min<br>NACS 30-60min after birth