AnesthesiaNCT04617249
Median and Paramedian Anesthesia in Cesarean Section
A study testing median anesthesia and paramedian anesthesia in people with Anesthesia, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
The number of cesarean sections worldwide has markedly been increasing since 1985.Intrathecal anesthesia is preferred by most anesthesiologists over general anesthesia Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- median anesthesia and paramedian anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2020to 15 May 2021
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-42 years
- Scheduled for elective cesarean section
- ASA II
Who cannot join
- -Age <18 years or >42 years
- ASA >II
- Emergency cesarean section
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Aljazeera( Al Gazeera) hospital
Giza
Mahmoud Alalfy, PhD, +201002611058 ext. +2, mahmoudalalfy@ymail.com
About this study
Official title: Assessment of Different Routes Median and Paramedian Anesthesia in Cesarean Section
The number of cesarean sections worldwide has markedly been increasing since 1985.Intrathecal anesthesia is preferred by most anesthesiologists over general anesthesia
Read the detailed description
Complications with spinal anesthesia are not common which makes it difficult to detect its incidence and one of the most serious complications is nerve injury.
- Conditions
- Anesthesia
- Being tested
- median anesthesia, paramedian anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
median anesthesiaProcedure or surgery
giving median anesthesia
paramedian anesthesiaProcedure or surgery
giving paramedian anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Giving median anesthesia | Active comparator | Not described Receives: Procedure: median anesthesia |
| Giving paramedian anesthesia | Active comparator | Not described Receives: Procedure: paramedian anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of women who will have less pain
the number of women who will have less pain post procedure
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start5 Nov 2020 (estimated)
- Primary completion25 Apr 2021 (estimated)
- Study completion15 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- anesthesia with median route versus paramedian route
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, Study chair, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617249
- Sponsor's protocol ID
- anesthesia routes
- Status last verified
- Oct 2020
- First submitted
- 31 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Different Routes Median and Paramedian Anesthesia in Cesarean Section
- ClinicalTrials.gov ID
- NCT04617249
- Acronym / sponsor ID
- anesthesia routes
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 5 Nov 2020 (estimated)
- Primary completion
- 25 Apr 2021 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 5 Nov 2020 (actual)
- 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.
The number of cesarean sections worldwide has markedly been increasing since 1985.Intrathecal anesthesia is preferred by most anesthesiologists over general anesthesia
Detailed description
Complications with spinal anesthesia are not common which makes it difficult to detect its incidence and one of the most serious complications is nerve injury.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- anesthesia with median route versus paramedian route
| Arm | Type | Receives |
|---|---|---|
| Giving median anesthesia | Active comparator | Procedure: median anesthesia |
| Giving paramedian anesthesia | Active comparator | Procedure: paramedian anesthesia |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-42 years
- Scheduled for elective cesarean section
- ASA II
Key exclusion criteria (3 listed)
- -Age <18 years or >42 years
- ASA >II
- Emergency cesarean section
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 |
|---|---|---|
| median anesthesiagiving median anesthesia | Procedure or surgery | Giving median anesthesia |
| paramedian anesthesiagiving paramedian anesthesia | Procedure or surgery | Giving paramedian anesthesia |
Primary outcome
the number of women who will have less pain
Time frame: 3 days
the number of women who will have less pain post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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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.
Mahmoud Alalfy study chair
Algezeera hospitaland National Research Centre ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing median anesthesia and paramedian anesthesia in people with Anesthesia, run by Aljazeera Hospital 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 3 inclusion and 3 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 5 Nov 2020. 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 Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of women who will have less pain (time frame: 3 days). 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 5 Nov 2020.