Cesarean Section; DehiscencePhase 4NCT02714179
Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section
A Phase 4 study testing Paracetamol was given intravenously in both group at different times in people with Cesarean Section; Dehiscence, run by Baskent University.
Trial summary
The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores, patient satisfaction, total morphine consumption and the incidence of morphine-related side effects in patients undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- Paracetamol was given intravenously in both group at different times
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2016
- Phase
- Phase 4
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 38 weeks pregnancy, elective cesarean section.
- -
Who cannot join
- morbid obesity, cardiac failure, depression.
About this study
Official title: A Double Blind Randomised Controlled Trial of Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section
The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores, patient satisfaction, total morphine consumption and the incidence of morphine-related side effects in patients undergoing cesarean section.
- Conditions
- Cesarean Section; Dehiscence
- Being tested
- Paracetamol was given intravenously in both group at different times
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol was given intravenously in both group at different timesDrug
| Study group | Role | What they receive |
|---|---|---|
| Group Preemptive (Group PE), | Active comparator | Group I: i.V. paracetamol 1 g (100 ml) was given 30 min before induction of anesthesia. Receives: Drug: Paracetamol was given intravenously in both group at different times |
| Group Preventive (Group PV), | Active comparator | Group II: i.V. paracetamol 1 g (100 ml) was given before the end of surgery. Receives: Drug: Paracetamol was given intravenously in both group at different times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog score (VAS) for pain
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; DehiscenceStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Ozmete, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714179
- Sponsor's protocol ID
- KA15/80
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2016
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomised Controlled Trial of Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section
- ClinicalTrials.gov ID
- NCT02714179
- Acronym / sponsor ID
- KA15/80
- Conditions
- Cesarean Section; Dehiscence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Mar 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.
The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores, patient satisfaction, total morphine consumption and the incidence of morphine-related side effects in patients undergoing cesarean section.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Preemptive (Group PE), | Active comparator | Drug: Paracetamol was given intravenously in both group at different timesGroup I: i.V. paracetamol 1 g (100 ml) was given 30 min before induction of anesthesia. |
| Group Preventive (Group PV), | Active comparator | Drug: Paracetamol was given intravenously in both group at different timesGroup II: i.V. paracetamol 1 g (100 ml) was given before the end of surgery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 38 weeks pregnancy, elective cesarean section.
- -
Key exclusion criteria (1 listed)
- morbid obesity, cardiac failure, depression.
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 |
|---|---|---|
| Paracetamol was given intravenously in both group at different times | Drug | Group Preemptive (Group PE),, Group Preventive (Group PV), |
Primary outcome
Visual analog score (VAS) for pain
Time frame: 24 hours
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 21 Mar 2016.
Related trials for Cesarean Section; Dehiscence
Not yet recruitingObservational study
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
Not yet recruiting
Effect of Bioptron Light Therapy on Wound Healing After Caesarean Section
Cesarean Section; Complications, Wound, Dehiscence
Recruiting
Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions
Cesarean Section, Surgical Site Infection
Active, not recruitingObservational study
The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction
Cesarean Section; Dehiscence
Recruiting
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
Cesarean Section; Dehiscence
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol was given intravenously in both group at different times in people with Cesarean Section; Dehiscence, run by Baskent University.
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 2 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 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual analog score (VAS) for pain (time frame: 24 hours). 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 21 Mar 2016.