Comparison of Regimens MPIB, CIPCEA, PCEA

NCT02278601 | Active Not Recruiting Phase 3

• 1 other identifier: CTGL13feb013
• Study Type: interventional
• Target: 839
• Locations: 1 country
• Sites: 1

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.

Conditions

Breakthrough Pain

Keywords

Breakthrough pain

Outcome Measures

Primary Outcomes (1)

• Number of subjects with Breakthrough pain

  Unscheduled epidural supplementation by anaesthetist due to pain

  1 day

Secondary Outcomes (8)

• Number of subjects with Caesarean section

  1 day

• Number of subjects with Instrumental delivery

  1 day

• Foetal outcome

  1 day

• Willingness to pay

  1 day

• Factors associated with epidural decisions

  1 day

Study Arms (3)

MPIB modified programmed intermittent bolus

EXPERIMENTAL

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

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

CIPCEA

EXPERIMENTAL

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

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

patient controlled epidural analgesia with basal infusion

ACTIVE COMPARATOR

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

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

Interventions

epidural delivery system 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

CIPCEA; MPIB modified programmed intermittent bolus; patient controlled epidural analgesia with basal infusion

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

Also known as: amide local anaesthetic

CIPCEA; MPIB modified programmed intermittent bolus; patient controlled epidural analgesia with basal infusion

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

Also known as: opioid

CIPCEA; MPIB modified programmed intermittent bolus; patient controlled epidural analgesia with basal infusion

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (1)

• 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.

  PMID: 30202425 DERIVED

MeSH Terms

Conditions

Breakthrough Pain

Interventions

Ropivacaine; Fentanyl; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Ban L Sng, FANZCA

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: October 30, 2014
• Study Start: January 28, 2015
• Primary Completion: May 6, 2019
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

SG (1)