Conventional patient controlled epidural analgesia (PCEA) versus programmed intermittent epidural boluses (PIEB) for labor analgesia: a randomized, double blind study in nulliparous wome

Phase 1

• Conditions: providing adequate analgesia during labor and child birth; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-004600-30-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-19
• Study Completion: 2017-02-27
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

Nulliparous, term, singleton pregnancies with spontaneous or induced labor
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-ASA 3, 4 and 5
-Cervical dilatation >7cm
-Inability to perform evaluation
-Age <18 years
-Intolerance to any of the drugs used in the study
-Coagulopathy or infection
-Clinical evidence of peripheral neuropathies
-Refusal to sign informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified