- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011150
Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour (VVAMB)
Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, up to 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. There is also higher risk of motor blockade found in those receiving epidural analgesia, and these factors is associated with dysfunctional labour requiring obstetric intervention (instrumental delivery). Automated mandatory bolus (AMB) of variable-frequency (VAMB) has been shown to provide better pain relief as compared with conventional patient-controlled epidural analgesia (PCEA) with basal infusion, however its long lockout time per hour is associated with unsuccessful patient bolus requests, with similar motor block to conventional regimens.
The investigators therefore proposes to develop a novel epidural delivery regimen: Variable volume AMB (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries. This algorithm development including pilot and clinical trial will compare VVAMB with VAMB regimens, in reducing the incidence of motor block in 216 term women requesting for labour epidural analgesia.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 229899
- Recruiting
- KK Women's and Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation);
- Singleton fetus;
- In early labor stage (cervical dilation ≤5cm);
- Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol.
Exclusion Criteria:
- Non-cephalic fetal presentation;
- Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
- Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours;
- Dural puncture/ suspected dural puncture at initiation of CSEA.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Variable volume Automated Mandatory Bolus (VVAMB)
The anaesthetic drug and pain medication are prepared in an epidural infusion pump with the VVAMB programme.
The programme uses higher doses with lower frequency of medication (ropivacaine and fentanyl), and a patient control button for the patient to control the additional pain relief demands depending on the requirements during labour.
|
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Other Names:
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Other Names:
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Other Names:
|
Active Comparator: Automated mandatory bolus (AMB) of variable-frequency (VAMB)
The anaesthetic drug and pain medication are prepared in an epidural infusion pump with the VAMB programme.
The programme uses lower doses with more frequency of medication (ropivacaine and fentanyl), and a patient control button for the patient to control the additional pain relief demands depending on the requirements during labour.
|
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Other Names:
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Other Names:
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of motor block in each group
Time Frame: During labour (1 day)
|
The number of event of motor block throughout the labour.
Previous studies have shown that epidural analgesia using high concentrations of local anaesthetics could lead to decreased motor functions, and are subsequently associated with an increased incidence of instrumented delivery and longer second stage of labour.
In this study, the intensity of motor block is assessed by the patient's ability to move their lower extremities via a modified Bromage scale.
In the modified version, a scoring of 0 implies no motor block (Free movement of both legs and feet), scoring of 1 implies partial block (Just able to flex knees with free movement of feet), 2 implies almost complete block (Unable to flex knees but with free movement of feet) and 3 implies a full block (Unable to move legs/ feet).
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During labour (1 day)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with Instrumental delivery
Time Frame: During labour (1 day)
|
The number of subjects in each group having instrumental delivery (forceps, vacuum delivery)
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During labour (1 day)
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Number of subjects with Breakthrough pain
Time Frame: During labour (1 day)
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The number of subjects in each group having unscheduled epidural supplementation by anaesthetist due to labor pain
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During labour (1 day)
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APGAR score
Time Frame: After delivery (1 day)
|
The Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score is a test given to newborns soon after birth.
In the test, five are being evaluated: Appearance (skin color), Pulse (heart rate), Grimace response (reflexes), Activity (muscle tone) and Respiration (breathing rate and effort).
Each is scored on a scale of 0 to 2, with 2 being the best score; a total score of ten represents the best possible condition.
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After delivery (1 day)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Labor Pain
- Breakthrough Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics
- Fentanyl
- Anesthetics, Local
- Ropivacaine
Other Study ID Numbers
- AM/CT001/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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