An Observational Study Investigating the Positioning of Epidural Catheters and Their Function During Labour Analgesia

Labour Analgesia, Epidural Anaesthesia Clinical Trial

Official title:

An Observational Study Investigating the Influence of Physical Position of Epidural Catheters and Their Function During Labour Analgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02924779
• Other study ID #: RotkreuzklinikumMunchen
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2016
• Last updated: October 3, 2016
• Start date: June 2016

Study information

• Verified date: October 2016
• Source: Rotkreuzklinikum München gGmbH
• Contact: Ellis Muggleton, MBChB
• Phone: 015756216128
• Email: ellis.muggleton[@]gmail.com
• Is FDA regulated: No
• Health authority: Germany: BLäK
• Study type: Observational

Clinical Trial Summary

This is a small observational study investigating the physical changes that occur to epidural catheters after insertion for obstetric anaesthesia. Using the observed physical changes as a correlate for the position of the catheter in the patient we will investigate a connection between the position and e function during labour. This information may be useful in guiding the physicians responses to epidurals that do not provide adequate analgesia to aid in deciding on the most appropriate action

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• any women in labour requesting epidural anaesthesia

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Labour Analgesia, Epidural Anaesthesia

Intervention

Other:
• No intervention
Retrospective observational study

Locations

Country	Name	City	State
Germany	Frauenklinik Taxisstrasse	München	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Rotkreuzklinikum München gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Position of epidural catheter	the structural form of the epidural catheter will be noted	directly after removal of the epidural	No
Primary	Analgesia effectiveness	All women will be asked about the effectiveness of the epidural catheter during birth	directly after removal of the epidural	No
Secondary	secondary caesarean section	the proportion of epidurals that were subsequently used for a caesarean section	directly after removal of the epidural	No
Secondary	Impact on motor function	the effect of the epidural catheter on leg strength and the ability of women to ambulate	directly after removal of the epidural	No