Spinal AnesthesiaNCT02937792
Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section
A study testing intrathecal 15 mg bupivacaine in people with Spinal Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
To test the safety of high dose spinal in elective CS after prolonged sitting position. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- intrathecal 15 mg bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Full term pregnant female indicated for the elective section under spinal anesthesia with no history of medical importance
Who cannot join
- Urgent cases, emergency cases, adverse medical history, anticoagulant treatment, associated pregnancy complication, failed spinal, surgical complication or refusal
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Giza Governorate, 1234
HASSAN M ALI, LECTURER, +201001733687, hassan364@hotmail.com
About this study
To test the safety of high dose spinal in elective CS after prolonged sitting position.
Read the 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.
- Conditions
- Spinal Anesthesia
- Being tested
- intrathecal 15 mg bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal 15 mg bupivacaineDrug
Also called large dose spinal
spinal anesthesia with a large dose of bupivacaine 0.5% in elective caesarean section
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | one with intrathecal 12.5 mg bupivacaine |
| experimental | Experimental | one group with intrathecal 15 mg bupivacaine Receives: Drug: intrathecal 15 mg bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital signs
blood pressure, heart rate
Measured: 45 minutes
Secondary outcomes (1)
complications
nausea, vomiting and total spinal
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937792
- Sponsor's protocol ID
- 3 ml bupivacaine
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section
- ClinicalTrials.gov ID
- NCT02937792
- Acronym / sponsor ID
- 3 ml bupivacaine
- Conditions
- Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –one with intrathecal 12.5 mg bupivacaine |
| experimental | Experimental | Drug: intrathecal 15 mg bupivacaineone group with intrathecal 15 mg bupivacaine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Full term pregnant female indicated for the elective section under spinal anesthesia with no history of medical importance
Key exclusion criteria (1 listed)
- Urgent cases, emergency cases, adverse medical history, anticoagulant treatment, associated pregnancy complication, failed spinal, surgical complication or refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrathecal 15 mg bupivacaineAlso: large dose spinalspinal anesthesia with a large dose of bupivacaine 0.5% in elective caesarean section | Drug | experimental |
Primary outcome
vital signs
Time frame: 45 minutes
blood pressure, heart rate
1 secondary outcome
complications
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrathecal 15 mg bupivacaine in people with Spinal Anesthesia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan Ali, lecturer (1001733687, hassan364@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital signs (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.