Cesarean Section; DehiscencePhase 4NCT02369133
Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control
A Phase 4 study testing paracetamol 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 paracetamol on postoperative pain scores, patient satisfaction, total morfin consumption and the incidence of morfin-related side effects in patients undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Nov 2014
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between the ages of 20-40 years,
- ASA physical status 1-2 who underwent elective cesarean surgery during general anesthesia were included in the study
Who cannot join
- A history of allergy to any of the study medications (opiod, general anesthetic agents or paracetamol),
- history of opioid or paracetamol use,
- hepatic or renal failure,
- any psychological disorders,
- complications during cesarean section and unable to use PCIA device were excluded from the study.
About this study
Official title: Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control : A Randomized Controlled Trial
The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction, total morfin consumption and the incidence of morfin-related side effects in patients undergoing cesarean section.
- Conditions
- Cesarean Section; Dehiscence
- Being tested
- paracetamol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol, patients in group S (n = 30) received 100 ml iv %0.9 NaCl
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Group Paracetamol (Group P), | Active comparator | Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol Receives: Drug: paracetamol |
| Group Saline (Group S) | Placebo comparator | Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group S (n = 30) received 100 ml iv %0,9 saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores measured by visual analog scale (VAS)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionNov 2014
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 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
- NCT02369133
- Sponsor's protocol ID
- KA 13-180
- Status last verified
- Feb 2015
- First submitted
- 17 Feb 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02369133
- Acronym / sponsor ID
- KA 13-180
- Conditions
- Cesarean Section; Dehiscence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Feb 2015 (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 paracetamol on postoperative pain scores, patient satisfaction, total morfin consumption and the incidence of morfin-related side effects in patients undergoing cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Paracetamol (Group P), | Active comparator | Drug: paracetamolDrugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol |
| Group Saline (Group S) | Placebo comparator | Drug: PlaceboDrugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group S (n = 30) received 100 ml iv %0,9 saline |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients between the ages of 20-40 years,
- ASA physical status 1-2 who underwent elective cesarean surgery during general anesthesia were included in the study
Key exclusion criteria (5 listed)
- A history of allergy to any of the study medications (opiod, general anesthetic agents or paracetamol),
- history of opioid or paracetamol use,
- hepatic or renal failure,
- any psychological disorders,
- complications during cesarean section and unable to use PCIA device were excluded from the study.
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 |
|---|---|---|
| paracetamolDrugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol, patients in group S (n = 30) received 100 ml iv %0.9 NaCl | Drug | Group Paracetamol (Group P), |
| Placebo | Drug | Group Saline (Group S) |
Primary outcome
Postoperative pain scores measured by visual analog scale (VAS)
Time frame: Postoperative 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 23 Feb 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paracetamol 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 5 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 23 Feb 2015. 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. 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 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?
Postoperative pain scores measured by visual analog scale (VAS) (time frame: Postoperative 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 23 Feb 2015.