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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

Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date February 26, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
Incidence of motor block in each group [ Time Frame: During labour (1 day) ]
The number of event of motor block throughout the labour. Motor block is assessed via modified Bromage scale to determine the motor function once local anaesthetics are given. A scoring of 0 implies no motor block, whereas scoring of 1-3 implies a partial to full block.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • 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)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour
Official Title  ICMJE Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Labor Pain
  • Breakthrough Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Epidural infusion pump
    • Drug: Ropivacaine
    • Drug: Fentanyl
  • 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.
    Interventions:
    • Device: Epidural infusion pump
    • Drug: Ropivacaine
    • Drug: Fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019)
216
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only females having natural delivery in KKH will be recruited.
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ban Leong Sng, FANZCA +6563941081 sng.ban.leong@kkh.com.sg
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011150
Other Study ID Numbers  ICMJE AM/CT001/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party KK Women's and Children's Hospital
Study Sponsor  ICMJE KK Women's and Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wan Ling Leong, FANZCA KK Women's and Children's Hospital
PRS Account KK Women's and Children's Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP