Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section

Spinal Anesthesia Clinical Trial

Official title:

Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02937792
• Other study ID #: 3 ml bupivacaine
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2016
• Last updated: October 18, 2016
• Start date: October 2016
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: Hassan Ali, lecturer
• Phone: 1001733687
• Email: hassan364[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

To test the safety of high dose spinal in elective CS after prolonged sitting position.

Description:

This is a prospective double-blind randomized study, designed to include cases in two groups (using epical program for sample size calculation), one study groups and one control group (parallel). Each group should have at least 30 female patients scheduled for elective caesarean section with a total of 60 cases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Full term pregnant female indicated for the elective section under spinal anesthesia with no history of medical importance

Exclusion Criteria:

• Urgent cases, emergency cases, adverse medical history, anticoagulant treatment, associated pregnancy complication, failed spinal, surgical complication or refusal

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• intrathecal 15 mg bupivacaine
spinal anesthesia with a large dose of bupivacaine 0.5% in elective caesarean section

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vital signs	blood pressure, heart rate	45 minutes	Yes
Secondary	complications	nausea, vomiting and total spinal	45 minutes	Yes