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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age21-50
SponsorKK Women's and Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Epidural infusion pump

    Device

    Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

  • Ropivacaine

    Drug

    Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

  • Fentanyl

    Drug

    Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: Variable volume Automated Mandatory Bolus (VVAMB)Experimental treatment 3 interventions
Group B: Automated mandatory bolus (AMB) of variable-frequency (VAMB)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of motor block in each group

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).

Time frame
During labour (1 day)

Secondary outcomes

1

Number of subjects with Instrumental delivery

The number of subjects in each group having instrumental delivery (forceps, vacuum delivery)

Time frame
During labour (1 day)
2

Number of subjects with Breakthrough pain

The number of subjects in each group having unscheduled epidural supplementation by anaesthetist due to labor pain

Time frame
During labour (1 day)
3

APGAR score

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.

Time frame
After delivery (1 day)

Other outcomes

Sponsors and contacts

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