Labor Pain
Conditions
Keywords
Labor Pain, Analgesia, Epidural
Brief summary
Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter. Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal. This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.
Interventions
Sponsors
Kai Schoenhage
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 53 Years
Healthy volunteers
No
Inclusion criteria
* in labor * labor pain \>3 on visual analog scale (VAS)
Exclusion criteria
* cardiovascular disease * preeclampsia * diabetes mel-litus * thyroid disease * current (outpatient) opioid medication * recent and / or current use of cocaine * seizure disorder * psychiatric disease * body mass index \>35 * preterm labor (\<37 weeks pregnant) * known allergies to any of the three study substances
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction of pain score on a visual analog scale (VAS) of 1-10 | 0-30 minutes | semi-quantitative assessment of decrease in the subject's pain score after administration of the study drug for the placement of an epidural catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| movement during epidural placement | 0-30 minutes | semi-quantitative assessment of the subject's movement during placement of the epidural catheter: 0-1-2-3: none - extremities - trunk a bit - trunk a lot |
| position during epidural placement | 0-30 minutes | semi-quantitative assessment of the subject's position during the epidural catheter placement: 0-1-2: excellent - moderate - poor |
Other
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic and oxygenation assessment of parturient and fetus, side effects | 0-30 minutes | heart rate (HR), non-invasive blood pressure (NIBP), pulse-oximetry (SpO2), fetal heart rate (FHR), uterine contractions (CTG - cardiotocogram); feeling of being jittery, pruritus and nausea |
Countries
United States
Contacts
Primary ContactKai Schoenhage, MD
Outcome results
None listed