Breakthrough Pain Computer Integrated Patient Controlled Epidural Analgesia

Completed

• Conditions: Pain

• Registration Number: NCT02313571
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

• Nulliparous women,
• requested for epidural analgesia

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breakthrough Pain (Requiring unscheduled epidural supplementation by anaesthetists)	1 day	Requiring unscheduled epidural supplementation by anaesthetists

Secondary Outcome Measures

Name	Time	Method
Caesarean Section (Rate of caesarean section)	1 day	Rate of caesarean section
Instrumental Delivery (Rate of instrumental delivery)	1 day	Rate of instrumental delivery

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore