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NCT Number: NCT02313571

Breakthrough Pain Computer Integrated Patient Controlled Epidural Analgesia

The computer-integrated patient controlled epidural analgesia (CIPCEA) system can automatically adjust the background infusion rate during combined spinal-epidural (CSE) analgesia based on the parturient's need as labour progresses. Analysis of parturients experiencing breakthrough pain may identify associated factors that can also be related to obstetric or foetal outcomes

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Key information

Conditions

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

Age range

21 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

Computer integrated patient controlled epidural analgesia (CIPCEA) is a novel epidural analgesic delivery system that is currently used in daily practice in KK Women's and Children's Hospital. It has enabled us to monitor the infusion pumps through wireless connection to a central monitoring system and hence, collect pump utilisation data electronically. The CIPCEA system is programmed to analyse the LA usage across the last hour and adjust the background infusion rate according to a preset algorithm.

Breakthrough pain is defined as maternal complaint of pain or pressure that required and was successfully treated with supplemental epidural medications. we investigated the potential factors associated with breakthrough pain in patients who receive CSE epidural analgesia with CIPCEA, with the aim of elucidating the important associated factors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparous women,
  • requested for epidural analgesia

Exclusion criteria

  • Multiparous women,
  • unable to perform combined spinal epidural technique

Treatment and study plan

Primary outcomes

  1. Breakthrough Pain (Requiring unscheduled epidural supplementation by anaesthetists)

    Time frame: 1 day

    Requiring unscheduled epidural supplementation by anaesthetists

Secondary outcomes

  1. Caesarean Section (Rate of caesarean section)

    Time frame: 1 day

    Rate of caesarean section

  2. Instrumental Delivery (Rate of instrumental delivery)

    Time frame: 1 day

    Rate of instrumental delivery

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

Incidence and Characteristics of Breakthrough Pain in Parturients Using Computer Integrated Patient Controlled Epidural Analgesia

Acronym: BTP

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2014
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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