Comparison of the ED95 dose of 0.075% and 0.1% bupivacaine for labour analgesia in primigravida - MED and Epidural Bupivacaine

Phase 1

• Conditions: Patients pregnant for the first time(primigravida)in early labour requesting epidural analgesia for pain relief.

• Registration Number: EUCTR2010-020020-21-GB
• Lead Sponsor: eeds Teaching Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

ASA 1-3 patients
Age > 18 years
Primigravida (1st pregnancy) patients requesting epidural analgesia in early labour (= 5 cm cervical dilatation

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Primigravida (1st pregnancy) patients requesting epidural analgesia in late labour (> 5 cm cervical dilatation)
Multigravida patients ( = 2nd pregnancy)
ASA > 3
Age < 18 years
Allergy to Bupivacaine
Unable to give written informed consent
BMI >35
Abnormal blood coagulation profile
Patients taking any medication that are indicated in the SPC as not recommended

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: None;<br> Primary end point(s): To find out the ED95 dose of bupivacaine 0.075% and 0.1% for epidural analgesia for a primigravida in early labour .<br><br> ;Main Objective: What is the dose of bupivacaine 0.075% and bupivacaine 0.1% that has 95% chance of success for epidural pain relief, during early part of labour, for a woman having first child.