AnalgesiaNCT04405336
Tab Block and Patient Controlled Analgesia in CS
A study testing tab block, PCA and women who will not receive tab block or PCA in people with Analgesia, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
cesarean section rate become increasing nowadays Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- tab block, PCA and women who will not receive tab block or PCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 28 May 2020to 1 Apr 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- women coming for an elective CS
Who cannot join
- women who has a n emergency CS or complicated normal deivery needs urgent CS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tab Block and Patient Controlled Analgesia in Cesarean Section
cesarean section rate become increasing nowadays
Read the detailed description
indication of cesarean section are different from case to case and the use of pain controlling agents is very important to relieve post operative pain
- Conditions
- Analgesia
- Being tested
- tab block, PCA, women who will not receive tab block or PCA
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tab blockDrug
injection of tab block to women who are doing cs
PCADrug
giving women PCA
women who will not receive tab block or PCADrug
no tab block or PCA will be given
| Study group | Role | What they receive |
|---|---|---|
| giving tab block | Active comparator | giving patients tab block Receives: Drug: tab block; Drug: women who will not receive tab block or PCA |
| giving PCA | Active comparator | Giving PCA to patients Receives: Drug: PCA; Drug: women who will not receive tab block or PCA |
| Patients who will not receive PCA or tab block | No intervention | No tab block or PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will feel less pain post CS
the degree of pain that will be felt post CS
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start28 May 2020
- Primary completion15 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Study chair, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405336
- Sponsor's protocol ID
- tab block
- Status last verified
- May 2021
- First submitted
- 23 May 2020
- Last updated
- 25 May 2021
- 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 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tab Block and Patient Controlled Analgesia in Cesarean Section
- ClinicalTrials.gov ID
- NCT04405336
- Acronym / sponsor ID
- tab block
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 28 May 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.
cesarean section rate become increasing nowadays
Detailed description
indication of cesarean section are different from case to case and the use of pain controlling agents is very important to relieve post operative pain
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| giving tab block | Active comparator | Drug: tab block, Drug: women who will not receive tab block or PCAgiving patients tab block |
| giving PCA | Active comparator | Drug: PCA, Drug: women who will not receive tab block or PCAGiving PCA to patients |
| Patients who will not receive PCA or tab block | No intervention | –No tab block or PCA |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women coming for an elective CS
Key exclusion criteria (1 listed)
- women who has a n emergency CS or complicated normal deivery needs urgent CS
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 |
|---|---|---|
| tab blockinjection of tab block to women who are doing cs | Drug | giving tab block |
| PCAgiving women PCA | Drug | giving PCA |
| women who will not receive tab block or PCAno tab block or PCA will be given | Drug | giving PCA, giving tab block |
Primary outcome
The number of women who will feel less pain post CS
Time frame: 2 days
the degree of pain that will be felt post CS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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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, PhD 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 tab block, PCA and women who will not receive tab block or PCA in people with Analgesia, 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 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: finished, as of the sponsor's last update on 25 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women who will feel less pain post CS (time frame: 2 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 25 May 2021.