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Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour (VVAMB)

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ClinicalTrials.gov Identifier: NCT04011150
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Brief Summary:
A novel epidural delivery regimen was developed: Variable volume automated mandatory bolus (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.

Condition or disease Intervention/treatment Phase
Labor Pain Breakthrough Pain Device: Epidural infusion pump Drug: Ropivacaine Drug: Fentanyl Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl

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.
Device: Epidural infusion pump
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 Name: Epidural delivery system

Drug: Ropivacaine
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 Name: Amide local anaesthetic

Drug: Fentanyl
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 Name: Opioid

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.
Device: Epidural infusion pump
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 Name: Epidural delivery system

Drug: Ropivacaine
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 Name: Amide local anaesthetic

Drug: Fentanyl
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 Name: Opioid




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. Number of subjects with Breakthrough pain [ Time Frame: During labour (1 day) ]
    The number of subjects in each group having unscheduled epidural supplementation by anaesthetist due to labor pain

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females having natural delivery in KKH will be recruited.
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011150


Contacts
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Contact: Ban Leong Sng, FANZCA +6563941081 sng.ban.leong@kkh.com.sg

Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
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Principal Investigator: Wan Ling Leong, FANZCA KK Women's and Children's Hospital
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT04011150    
Other Study ID Numbers: AM/CT001/2018
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by KK Women's and Children's Hospital:
Labor Pain
Breakthrough Pain
Infusion pump
Additional relevant MeSH terms:
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Labor Pain
Breakthrough Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General