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NCT02313571 Clinical Trial

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
Secondary ID
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

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
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