Pain Relief During LabourPhase 4NCT01909089
Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour
A Phase 4 study testing Spinal administration of chloroprocaine. in people with Pain Relief During Labour, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Relief During Labour
- What is being tested?
- Spinal administration of chloroprocaine.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Oct 2013to 18 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women in labour with a gestational period of 36 to 41 weeks
- ASA I or II
- Primi- and multiparae
- Spontaneous or induced labor
Who cannot join
- Pregnant women in labour who received opiates or analgetics during the 6 hour period prior to CSE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour.
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.
Read more
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.
- Conditions
- Pain Relief During Labour
- Being tested
- Spinal administration of chloroprocaine.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal administration of chloroprocaine.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine | Experimental | Up-down sequential allocation. Receives: Drug: Spinal administration of chloroprocaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of sensory blockade 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.
Measured: 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 motor blockade is determined by the adjusted Bromage scale:
- = complete motor block with the impossibility to move the legs
- = only the possibility to move the feet
- = possibility to move the knees
- = weak flexion of the hips
- = a complete flexion of the hips and the knees
Prior to the application of the CSE the patients are asked to perform the motor tests to exclude neurological disorders.
Measured: 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.
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.
Measured: During the next 15 minutes after the application of the CSE.
Secondary outcomes (4)
Maternal heart rate during application of the CSE and the hour there after.
Measured: During application of the CSE and the hour there after.
Maternal blood pressure during application of the CSE and the hour there after.
Measured: During application of the CSE and the hour there after.
Maternal oxygen saturation during application of the CSE and the hour there after.
Measured: During application of the CSE and the hour there after.
Fetal heart rate during application of the CSE and the hour there after.
Measured: During application of the CSE and the hour there after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study start17 Oct 2013
- Primary completion21 Aug 2015
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief During LabourStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Coppens, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909089
- Sponsor's protocol ID
- 2013/334
- Other IDs
- 2013-001703-37
- Status last verified
- Dec 2022
- First submitted
- 23 Jul 2013
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour.
- ClinicalTrials.gov ID
- NCT01909089
- Acronym / sponsor ID
- 2013/334
- Conditions
- Pain Relief During Labour
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 17 Oct 2013 (actual)
- Primary completion
- 21 Aug 2015 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine | Experimental | Drug: Spinal administration of chloroprocaine.Up-down sequential allocation. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women in labour with a gestational period of 36 to 41 weeks
- ASA I or II
- Primi- and multiparae
- Spontaneous or induced labor
Key exclusion criteria (1 listed)
- Pregnant women in labour who received opiates or analgetics during the 6 hour period prior to CSE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Chloroprocaine |
Primary outcome
Intensity of sensory blockade during the next 15 minutes after the application of the CSE.
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.
Intensity of the motor blockade during the next 15 minutes after the application of the CSE.
Time frame: During the next 15 minutes after the application of the CSE.
The motor blockade is determined by the adjusted Bromage scale: 1. = complete motor block with the impossibility to move the legs 2. = only the possibility to move the feet 3. = possibility to move the knees 4. = weak flexion of the hips 5. = a complete flexion of the hips and the knees Prior to the application of the CSE the patients are asked to perform the motor tests to exclude neurological disorders.
The analgesic effect on the labor pain during the next 15 minutes after the application of the CSE.
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: * 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.
4 secondary outcomes
Maternal heart rate during application of the CSE and the hour there after.
Time frame: During application of the CSE and the hour there after.
Maternal blood pressure during application of the CSE and the hour there after.
Time frame: During application of the CSE and the hour there after.
Maternal oxygen saturation during application of the CSE and the hour there after.
Time frame: During application of the CSE and the hour there after.
Fetal heart rate during application of the CSE and the hour there after.
Time frame: During application of the CSE and the hour there after.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Coppens, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal administration of chloroprocaine. in people with Pain Relief During Labour, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of sensory blockade during the next 15 minutes after the application of the CSE. (time frame: During the next 15 minutes after the application of the CSE.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.