PainNCT03730246
Pain After Cesarean Sectio.
An observational study of Pain and Analgesic Medication, run by Oslo University Hospital at 1 site in Norway.
Trial summary
To study the strength of postoperative pain 0-24 hrs after elective cesarean sectio in spinal anaesthesia. Read more about this study
- Who is it for?
- Ages Up to 50 years, women only
- Conditions the study is for
- Pain, Analgesic Medication
- What is being tested?
- cesarean sectio
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2018to 31 Jul 2019
- Phase
- Observational
- 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 Up to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: all patients due for cesarean sectio are eligible
Who may be able to join
- cesearean sectio
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, 0407
Johan Raeder, PhD, 004792249669, johan.rader@medisin.uio.no
About this study
Official title: Postoperative Pain 0-24 hr After Cesarean Sectio
To study the strength of postoperative pain 0-24 hrs after elective cesarean sectio in spinal anaesthesia.
- Conditions
- Pain, Analgesic Medication
- Being tested
- cesarean sectio
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean sectioProcedure or surgery
consecutive parturients due for cesarean sectio
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain strenght
NRS pain
Measured: 0-24 hrs
Secondary outcomes (1)
rescue drug needed
dose of rescue opioid drug
Measured: 0-24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan C Ræder, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730246
- Sponsor's protocol ID
- Sectio.Pain.Jenny
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 5 Nov 2018
- 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 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain 0-24 hr After Cesarean Sectio
- ClinicalTrials.gov ID
- NCT03730246
- Acronym / sponsor ID
- Sectio.Pain.Jenny
- Conditions
- Pain, Analgesic Medication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 5 Nov 2018 (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.
To study the strength of postoperative pain 0-24 hrs after elective cesarean sectio in spinal anaesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all patients due for cesarean sectio are eligible
Key inclusion criteria (1 listed)
- cesearean sectio
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| cesarean sectioconsecutive parturients due for cesarean sectio | Procedure or surgery | – |
Primary outcome
postoperative pain strenght
Time frame: 0-24 hrs
NRS pain
1 secondary outcome
rescue drug needed
Time frame: 0-24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Analgesic Medication, run by Oslo University Hospital at 1 site in Norway.
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: status not confirmed, as of the sponsor's last update on 5 Nov 2018. 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 Norway. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain strenght (time frame: 0-24 hrs). 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 2018.