Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour
NCT ID: NCT01909089
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2013-10-17
2017-10-18
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chloroprocaine
Up-down sequential allocation.
Spinal administration of chloroprocaine.
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:
* effective: the VAPS is 10mm or lower after the 15 minutes of monitoring. An effective result will decrease the test dose of chloroprocaine with 2mg for the next patient in this study.
* Ineffective: the VAPS is more than 10mm after 15 minutes of monitoring. An ineffective result will increase the test dose of chloroprocaine with 2mg for the next patient in this study. Patients who indicate an ineffective result will receive a rescue treatment by the administration of 12ml levobupivacaine epidurally.
Interventions
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Spinal administration of chloroprocaine.
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:
* effective: the VAPS is 10mm or lower after the 15 minutes of monitoring. An effective result will decrease the test dose of chloroprocaine with 2mg for the next patient in this study.
* Ineffective: the VAPS is more than 10mm after 15 minutes of monitoring. An ineffective result will increase the test dose of chloroprocaine with 2mg for the next patient in this study. Patients who indicate an ineffective result will receive a rescue treatment by the administration of 12ml levobupivacaine epidurally.
Eligibility Criteria
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Inclusion Criteria
* ASA I or II
* Primi- and multiparae
* Spontaneous or induced labor
Exclusion Criteria
20 Years
45 Years
FEMALE
Yes
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Marc Coppens, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2013-001703-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2013/334
Identifier Type: -
Identifier Source: org_study_id