Determination of the subarachnoid ED50 and ED95 of hyperbaric 0.5% bupivacaine when co-administered with diamorphine hydrochloride for caesarean section

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004278-10-GB

Enrollment

Registered

2005-02-17

Start date

2005-02-10

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

patients undergoing elective caesarean section

Interventions

Trade Name: marcaine heavy Product Name: marcain heavy Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: women undergoing elective caesarean section 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: complicated pregnancy (multiple pregnancy, PIH, IUGR, placenta praevia), predicted difficult CS (>1 previous CS), contraindication to regional anaesthesia, height 175cm, age 40 years, pre-existing neurological disorder, non-English speaking patient

Design outcomes

Primary

Measure	Time frame
Main Objective: to determine the Ed50 and Ed95 of hyperbaric bupivacaine when used in combination with diamorphine, to provode spinal anaesthesia for caesarean section;Secondary Objective: ;Primary end point(s): success or failure of the spinal anaesthetic	—

Countries

United Kingdom

Outcome results

None listed

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