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

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

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

Study Overview

• Status: Unknown
• Conditions: Labour Analgesia, Epidural Anaesthesia
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • München, Bayern, Germany, 80637
      • Recruiting
      • Frauenklinik Taxisstrasse
      • Contact: Ellis Muggleton, MBChB; Phone Number: 015756216128; Email: ellis.muggleton@gmail.com
      • Sub-Investigator: Tülin Muggleton, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All women who request epidural analgesia during birth are eligible

Description

Inclusion Criteria:

• any women in labour requesting epidural anaesthesia

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women during labour; Women receiving lumbar epidural anaesthesia for pain during birth	Other: No intervention; Retrospective observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Position of epidural catheter	the structural form of the epidural catheter will be noted	directly after removal of the epidural
Analgesia effectiveness	All women will be asked about the effectiveness of the epidural catheter during birth	directly after removal of the epidural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary caesarean section	the proportion of epidurals that were subsequently used for a caesarean section	directly after removal of the epidural
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

Collaborators and Investigators

• Sponsor: Rotkreuzklinikum München gGmbH
• Investigators: Principal Investigator: Ellis Muggleton, MBChB, Anaesthetist Rotkreuzklinikum München

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): October 1, 2016
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: RotkreuzklinikumMunchen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No