Clinical trial NCT01909089: Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour
Official title: Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Relief During Labour
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria :

* Pregnant women in labour with a gestational period of 36 to 41 weeks
* ASA I or II
* Primi- and multiparae
* Spontaneous or induced labor

Exclusion criteria :

Pregnant women in labour who received opiates or analgetics during the 6 hour period prior to CSE

Primary outcomes:
measure: Intensity of sensory blockade during the next 15 minutes after the application of the CSE.
timeFrame: During the next 15 minutes after the application of the CSE.
measure: Intensity of the motor blockade during the next 15 minutes after the application of the CSE.
timeFrame: During the next 15 minutes after the application of the CSE.
measure: The analgesic effect on the labor pain during the next 15 minutes after the application of the CSE.
timeFrame: During the next 15 minutes after the application of the CSE.
Secondary outcomes:
measure: Maternal heart rate during application of the CSE and the hour there after.
timeFrame: During application of the CSE and the hour there after.
measure: Maternal blood pressure during application of the CSE and the hour there after.
timeFrame: During application of the CSE and the hour there after.
measure: Maternal oxygen saturation during application of the CSE and the hour there after.
timeFrame: During application of the CSE and the hour there after.
measure: Fetal heart rate during application of the CSE and the hour there after.
timeFrame: During application of the CSE and the hour there after.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Marc Coppens, MD
role: PRINCIPAL_INVESTIGATOR
References: