Determination of the subarachnoid ED50 and ED95 of hyperbaric 0.5% bupivacaine when co-administered with diamorphine hydrochloride for caesarean sectio
Phase 1
- Conditions
- patients undergoing elective caesarean section
- Registration Number
- EUCTR2004-004278-10-GB
- Lead Sponsor
- othian Health Board- University Hospitals Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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
complicated pregnancy (multiple pregnancy, PIH, IUGR, placenta praevia), predicted difficult CS (>1 previous CS), contraindication to regional anaesthesia, height < 150cm or > 175cm, age <18 or >40 years, pre-existing neurological disorder, non-English speaking patient
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method