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

October 18, 2016 updated by: Hassan Mohamed Ali, Cairo University
To test the safety of high dose spinal in elective CS after prolonged sitting position.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 1234
        • Recruiting
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL
one with intrathecal 12.5 mg bupivacaine
Experimental: experimental
one group with intrathecal 15 mg bupivacaine
Drug: intrathecal 15 mg bupivacaine
spinal anesthesia with a large dose of bupivacaine 0.5% in elective caesarean section
Other Names:
  • large dose spinal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vital signs
Time Frame: 45 minutes
blood pressure, heart rate
45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 45 minutes
nausea, vomiting and total spinal
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3 ml bupivacaine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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