Status:
COMPLETED
A Trial of the Use of Ultrasound to Aid the Insertion of Combined Spinal Epidural Anaesthesia
Lead Sponsor:
NHS Greater Glasgow and Clyde
Conditions:
Obesity
Pregnancy
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
The study will establish whether the use of ultrasound scanning with a purpose built probe will aid the insertion of the needles for epidural and spinal anaesthesia for obese women undergoing elective...
Detailed Description
Study objective: The clinical evaluation of a novel ultrasound probe to guide the insertion of central regional anaesthesia using a regional anaesthetic needle modified to aid insertion under ultraso...
Eligibility Criteria
Inclusion
- Elective Caesarean section \> 38/52 gestation
- BMI at booking scan (circia 13/52 gestation)\>=35
- ASA = 1,2 or 3 patients only
Exclusion
- Abnormal clotting screen (coagulopathy) or thrombocytopenia ( \< 100,000)
- Unable to give informed consent to combined spinal epidural anaesthesia
- Previous spinal surgery or known spinal pathology
- Signs, symptoms or laboratory evidence of local infection or systemic sepsis
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00166699
Start Date
September 1 2005
End Date
September 1 2007
Last Update
June 11 2008
Active Locations (5)
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1
Princess Royal maternity
Glasgow, Scotland, United Kingdom
2
Queen mother's maternity
Glasgow, Scotland, United Kingdom
3
Southern general maternity hospital
Glasgow, Scotland, United Kingdom
4
Paisley maternity hospital
Paisley, Scotland, United Kingdom