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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02937792

Enrollment

Registered

2016-10-19

Start date

2016-10-31

Completion date

2017-01-31

Last updated

2016-10-19

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

Conditions

Spinal Anesthesia

Brief summary

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

Detailed 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.

Interventions

DRUGintrathecal 15 mg bupivacaine

spinal anesthesia with a large dose of bupivacaine 0.5% in elective caesarean section

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
vital signs	45 minutes	blood pressure, heart rate

Secondary

Measure	Time frame	Description
complications	45 minutes	nausea, vomiting and total spinal

Countries

Egypt

Contacts

Primary ContactHassan Ali, lecturer

hassan364@hotmail.com1001733687

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026