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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020020-21-GB

Enrollment

100

Registered

2011-04-15

Start date

2011-07-12

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: 0.1% Bupivacaine Product Name: 0.1% bupivacaine Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Primigravida (1st pregnancy) patients requesting epidural analgesia in late labour (> 5 cm cervical dilatation) Multigravida patients ( = 2nd pregnancy) ASA > 3 Age 35 Abnormal blood coagulation profile Patients taking any medication that are indicated in the SPC as not recommended

Design outcomes

Primary

Measure	Time frame
Secondary Objective: None; 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 . ;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.	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026