Clinical Trial: Comparison of Regimens VAMB, CIPCEA, PCEA
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Comparison of Variable-frequency Automated Mandatory Bolus (VAMB), Computer-integrated Patient Controlled Epidural Analgesia (CIPCEA) and Conventional Patient Controlled Epidural Analgesia (PCEA) Duri
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 Summary: Our research team developed two novel epidural delivery regimens: computer-integrated PCEA (CIPCEA) (variable flexible background infusion) and variable-frequency automated mandatory bolus (VAMB) 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, 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.
Sponsor: KK Women's and Children's Hospital
Current Primary Outcome: Number of subjects with Breakthrough pain [ Time Frame: 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of subjects with Caesarean section [ Time Frame: 1 day ]Number of subjects with Caesarean section
- Number of subjects with Instrumental delivery [ Time Frame: 1 day ]Number of subjects with Instrumental delivery (forceps, vacuum delivery)
- Foetal outcome [ Time Frame: 1 day ]APGAR scores
Original Secondary Outcome: Same as current
Information By: KK Women's and Children's Hospital
Dates:
Date Received: October 26, 2014
Date Started: January 2015
Date Completion: December 2017
Last Updated: June 14, 2016
Last Verified: March 2016