Breakthrough Pain Computer Integrated Patient Controlled Epidural Analgesia

Pain Clinical Trial

— BTP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313571
• Other study ID #: 2012/061/D
• Status: Completed
• Phase: N/A
• First received: December 7, 2014
• Last updated: September 3, 2015
• Start date: March 2010
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• Nulliparous women,

• requested for epidural analgesia

Exclusion Criteria:

• Multiparous women,

• unable to perform combined spinal epidural technique

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breakthrough Pain
• Pain

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breakthrough Pain (Requiring unscheduled epidural supplementation by anaesthetists)	Requiring unscheduled epidural supplementation by anaesthetists	1 day	No
Secondary	Caesarean Section (Rate of caesarean section)	Rate of caesarean section	1 day	No
Secondary	Instrumental Delivery (Rate of instrumental delivery)	Rate of instrumental delivery	1 day	No