Ghent University Hospital
Ghent, 9000, Belgium
NCT Number: NCT01909089
Combined spinal-epidural (CSE) analgesia has become a widely accepted approach to provide analgesia for labour pain. Despite the increasingly widespread use of this technique, an optimal intrathecal drug regimen has not been established yet.
Several investigations using local anesthetics such as Bupivacaine, Levobupivacaine and Ropivacaine in CSE during labour have been published. But despite the reintroduction of Chloroprocaine recently there haven't been any investigations about spinal chloroprocaine. Chloroprocaine is already a long-know drug with a beneficial pharmacodynamic/kinetic profile. It is known for a very quick onset of action (2 - 3 minutes), high efficacy, rapid metabolism by plasma cholinesterases and short half-life both in mother and fetus.
Because of this beneficial profile, Chloroprocaine is widely used intrathecally for surgical anesthesia. Several investigations demonstrate that for surgical anesthesia doses Chloroprocaine ranging from 30 - 60 mg are used and that they have an effective surgical duration of 40 - 90 minutes.
Despite these "standards" for surgical anesthesia, little is known about spinal Chloroprocaine dose regimens. Therefore the primary goal of this study is to determine the minimum adequate dose of Chloroprocaine that is to be given spinally to a woman in labour using a CSE procedure. We will use the up-down sequential allocation to identify the median effective dose (ED50) or concentration (EC50).
The Effective dose in 95% of the population (ED95) can be estimated also from an up-down sequential allocation and will become an important valuable approximation of the clinical dose.
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Notify Me20 year–45 year
Female
Interventional
Phase 4
Ghent, 9000, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pregnant women in labour who received opiates or analgetics during the 6 hour period prior to CSE
In order to determine the minimum effective dose that is to be given spinally, an up-down sequential allocation will be used.
Efficacy of the analgesia will be evaluated by a 100mm visual analogue pain score (VAPS). There are two possible outcomes here:
Time frame: During the next 15 minutes after the application of the CSE.
The sensory blockade is determined by the difference in temperature sensation over the different dermatomes aided by ethylchloride spray.
Time frame: During the next 15 minutes after the application of the CSE.
The motor blockade is determined by the adjusted Bromage scale:
Prior to the application of the CSE the patients are asked to perform the motor tests to exclude neurological disorders.
Time frame: During the next 15 minutes after the application of the CSE.
Efficacy of the analgesia will be evaluated by a 100mm visual analogue pain score (VAPS). There are two possible outcomes here:
Time frame: During application of the CSE and the hour there after.
Time frame: During application of the CSE and the hour there after.
Time frame: During application of the CSE and the hour there after.
Time frame: During application of the CSE and the hour there after.
University Hospital, Ghent
Other
Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour.
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