Clinical trial NCT02278601: Comparison of Regimens MPIB, CIPCEA, PCEA
Official title: Comparison of Modified Programmed Intermittent Bolus (MPIB), Computer-integrated Patient Controlled Epidural Analgesia (CIPCEA) and Conventional Patient Controlled Epidural Analgesia (PCEA) During Labour
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breakthrough Pain
Keywords: Breakthrough pain
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2014-10-30
Enrollment: 839
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects with Breakthrough pain
timeFrame: 1 day
Secondary outcomes:
measure: Number of subjects with Caesarean section
timeFrame: 1 day
measure: Number of subjects with Instrumental delivery
timeFrame: 1 day
measure: Foetal outcome
timeFrame: 1 day
measure: Willingness to pay
timeFrame: 1 day
measure: Factors associated with epidural decisions
timeFrame: 1 day
measure: Pain vulnerability: Pain Catastrophizing Scale
timeFrame: 1 day
measure: Edinburgh Postnatal Depression Scale before and after delivery
timeFrame: 5-9 weeks
measure: Sub-acute pain after childbirth
timeFrame: 5-9 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban L Sng, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan DJA, Lew JP, Jumhasan MB, Pang C, Sultana R, Sng BL. Investigating factors associated with success of breastfeeding in first-time mothers undergoing epidural analgesia: a prospective cohort study. Int Breastfeed J. 2018 Sep 5;13:42. doi: 10.1186/s13006-018-0184-7. eCollection 2018.