Cesarean SectionPhase 2/3NCT04038307
Pre-emptive Paracetamol for Prevention of Intraoperative Shoulder Tip Pain
A Phase 2/3 study testing paracetamol and Saline Solution in people with Cesarean Section, run by Cairo University at 1 site in Egypt.
Trial summary
the aim is to determine the efficacy of Paracetamol in reducing the incidence and severity of intraoperative shoulder pain in patients undergoing cesarean section. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- paracetamol and Saline Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 1 Feb 2020
- Phase
- Phase 2/3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy pregnant women (ASA II) having singleton pregnancy at term (≤ 37 weeks of gestation) aged between 18 and 40 years.
Who cannot join
- Patients having allergy to study drug,
- gestational diabetes
- cardiovascular or biliary disorders
- asthma
- renal impairment
- preeclampsia
- any chronic pain condition or trauma in the shoulder, forearms or upper limbs
- patients with any contraindication to SA were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-emptive Intravenous Paracetamol for Prevention of Intraoperative Shoulder Tip Pain in Patients Undergoing Caesarean Section: A Randomized Double Blind Controlled Clinical Trial.
the aim is to determine the efficacy of Paracetamol in reducing the incidence and severity of intraoperative shoulder pain in patients undergoing cesarean section.
Read the detailed description
pregnant females scheduled for cesarean section under spinal anesthesia will be enrolled . two groups of patents will be recruited . the study group will receive paracetamol pre operative .
- Conditions
- Cesarean Section
- Being tested
- paracetamol, Saline Solution
- Keywords
- shoulder tip pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
1gm
Saline SolutionDrug
100ml
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | will receive 100 ml of saline Receives: Drug: Saline Solution |
| paracetamol group | Experimental | will receive 1gm paracetamol (100ml) Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence shoulder tip pain
presence of shoulder tip pain
Measured: intraoperative
Secondary outcomes (1)
numerical rating scale
severity of shoulder tip pain (0-10) where 0 is no pain and 10 is the worst pain ever
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Aug 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Hassab elnaby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038307
- Sponsor's protocol ID
- MS-12-2019
- Status last verified
- Jan 2020
- First submitted
- 24 Jul 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Intravenous Paracetamol for Prevention of Intraoperative Shoulder Tip Pain in Patients Undergoing Caesarean Section: A Randomized Double Blind Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04038307
- Acronym / sponsor ID
- MS-12-2019
- Conditions
- Cesarean Section
- Keywords
- shoulder tip pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 30 Jul 2019 (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 aim is to determine the efficacy of Paracetamol in reducing the incidence and severity of intraoperative shoulder pain in patients undergoing cesarean section.
Detailed description
pregnant females scheduled for cesarean section under spinal anesthesia will be enrolled . two groups of patents will be recruited . the study group will receive paracetamol pre operative .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: Saline Solutionwill receive 100 ml of saline |
| paracetamol group | Experimental | Drug: paracetamolwill receive 1gm paracetamol (100ml) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy pregnant women (ASA II) having singleton pregnancy at term (≤ 37 weeks of gestation) aged between 18 and 40 years.
Key exclusion criteria (8 listed)
- Patients having allergy to study drug,
- gestational diabetes
- cardiovascular or biliary disorders
- asthma
- renal impairment
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 |
|---|---|---|
| paracetamol1gm | Drug | paracetamol group |
| Saline Solution100ml | Drug | control |
Primary outcome
incidence shoulder tip pain
Time frame: intraoperative
presence of shoulder tip pain
1 secondary outcome
numerical rating scale
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
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Implementation of a Disparities in Labor Outcomes Dashboard
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing paracetamol and Saline Solution in people with Cesarean Section, 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 8 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 27 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
incidence shoulder tip pain (time frame: intraoperative). 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 27 Jan 2020.