CHLOROPROCAINE

Determination of the minimum local analgesic dose of spinal chloroprocaine in labor

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.
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. 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 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.
Primary outcomes:
Intensity of sensory blockade during the next 15 minutes after the application of the CSE.
Intensity of the motor blockade during the next 15 minutes after the application of the CSE.
The analgesic effect on the labor pain during the next 15 minutes after the application of the CSE.

  • Investigators UZ Gent : Dr. M. Coppens, Dr. S. Anssens
  • Timeline : start inclusion June 2013, 1 year
  • Clinical Trial.gov identifier : NCT01909089