Comparison of Regimens MPIB, CIPCEA, PCEA (COLEUS)

KK Women's and Children's Hospital

Status and phase: Active, not recruiting; Phase 3

Conditions: Breakthrough Pain

Treatments: Drug: Fentanyl; Device: epidural delivery system; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02278601

CTGL13feb013

Details and patient eligibility

About

Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more than 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. Women who have increased pain tend to have lower successful patient bolus demands when patient controlled epidural analgesia (PCEA) is utilised and have dysfunctional labour requiring obstetric intervention such as Caesarean or instrumental delivery. Labour pain often escalates and worsens as labour progresses requiring an individualized, variable, flexible analgesic regimen. Bolus epidural administrations have been shown to improve uniform spread of local anaesthetics with better pain relief, compared to fixed background infusions.

Full description

The research team developed two novel epidural delivery regimens: computer-integrated PCEA (CIPCEA) and modified programmed intermittent bolus (MPIB) focused on individualization of analgesic requirements. This phase 3 double-blinded randomized controlled trial will compare the two novel regimens, and each with conventional PCEA with basal infusion (BI), in reducing breakthrough pain (failure of the regimen to provide adequate pain relief, necessitating unscheduled epidural supplementation) incidence as the primary outcome in nulliparous term women requesting labour epidural analgesia. In addition, a discrete choice experiment (DCE) in the format of a survey will be administered to estimate the women's preferences in treatment attributes related to epidural analgesia, including control over epidural dosage, chance of having breakthrough pain, motor block, instrumental delivery and out-of-pocket cost for epidural analgesia. We will also look into the association model for breakthrough pain that would take into account pre-delivery factors to better understand the mechanism of breakthrough pain during labor process.

Enrollment: 839 patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy (ASA physical status 1 and 2) nulliparous parturients at term (≥36 weeks gestation);
2. Singleton foetus
3. Early labour (cervical dilation ≤5cm)
4. Request labour epidural analgesia
5. At least 21 years of age

Exclusion criteria

1. parturients with multiple pregnancies
2. non-cephalic foetal presentation
3. obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes, gestational diabetes on insulin) and uncontrolled medical (e.g. cardiac disease) complications
4. have contraindications to neuraxial blockade or have received parenteral opioids with the last 2 hours.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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839 participants in 3 patient groups

MPIB modified programmed intermittent bolus

Experimental group

Description:

Modified programmed intermittent bolus (MPIB) up-down frequency of 5mls ropivacaine/fentanyl solution in bolus with epidural delivery system

Treatment:

Drug: Ropivacaine

Device: epidural delivery system

Drug: Fentanyl

CIPCEA

Experimental group

Description:

computer integrated patient controlled epidural analgesia (CIPCEA) up-down variable basal infusion of ropivacaine/fentanyl solution with epidural delivery system

Treatment:

Drug: Ropivacaine

Device: epidural delivery system

Drug: Fentanyl

patient controlled epidural analgesia with basal infusion

Active Comparator group

Description:

patient controlled epidural analgesia (PCEA) with fixed basal infusion of ropivacaine/fentanyl solution with epidural delivery system

Treatment:

Drug: Ropivacaine

Device: epidural delivery system

Drug: Fentanyl