Cesarean SectionNCT00374504
Prediction of Postoperative Pain by an Electrical Pain Stimulus
An observational study of Cesarean Section, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate a possible correlation between predictive precesarean section pain and development of postcaesarean section pain using the PM. Patients and Methods 46 healthy pregnant women scheduled for elective cesarean section is included after informed consent. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy pregnant women scheduled for elective cesarean section
Who cannot join
- ASA III -IV
- Chronic pain conditions.
- Pacemaker.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Rrigshospitalet
Copenhagen, dk-2100
About this study
The aim of this study is to evaluate a possible correlation between predictive precesarean section pain and development of postcaesarean section pain using the PM.
Patients and Methods 46 healthy pregnant women scheduled for elective cesarean section is included after informed consent. The standard operation procedures included spinal anesthesia, paracetamol 1 g 8 hourly, diclofenac 50 mg 8 hourly and oxycontine 10 mg x 2. Morphine was used for break-through pain.
Read more
Before cesarian section the threshold for sensory and pain were measured 3 times, and the average was used for analyses. After cesarian section a blinded midwife assess the pain at rest and during mobilization every 12th hours over 2 days score.
Data was analyzed using AUC and non-parametric test, P < 0,05.
- Conditions
- Cesarean Section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Per Rotbøll Nielsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374504
- Sponsor's protocol ID
- 01 2745584
- Status last verified
- Feb 2006
- First submitted
- 8 Sep 2006
- Last updated
- 11 Sep 2006
- Results posted
- No
Publications
Nielsen PR, Norgaard L, Rasmussen LS, Kehlet H. Prediction of post-operative pain by an electrical pain stimulus. Acta Anaesthesiol Scand. 2007 May;51(5):582-6. doi: 10.1111/j.1399-6576.2007.01271.x.
PubMed 17430320
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Pain by an Electrical Pain Stimulus
- ClinicalTrials.gov ID
- NCT00374504
- Acronym / sponsor ID
- 01 2745584
- Conditions
- Cesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- First posted
- 11 Sep 2006 (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 aim of this study is to evaluate a possible correlation between predictive precesarean section pain and development of postcaesarean section pain using the PM.
Patients and Methods 46 healthy pregnant women scheduled for elective cesarean section is included after informed consent. The standard operation procedures included spinal anesthesia, paracetamol 1 g 8 hourly, diclofenac 50 mg 8 hourly and oxycontine 10 mg x 2. Morphine was used for break-through pain.
Before cesarian section the threshold for sensory and pain were measured 3 times, and the average was used for analyses. After cesarian section a blinded midwife assess the pain at rest and during mobilization every 12th hours over 2 days score.
Data was analyzed using AUC and non-parametric test, P < 0,05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy pregnant women scheduled for elective cesarean section
Key exclusion criteria (3 listed)
- ASA III -IV
- Chronic pain conditions.
- Pacemaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 11 Sep 2006.
- Derived from this study: PubMed 17430320Nielsen PR, Norgaard L, Rasmussen LS, Kehlet H. Prediction of post-operative pain by an electrical pain stimulus. Acta Anaesthesiol Scand. 2007 May;51(5):582-6. doi: 10.1111/j.1399-6576.2007.01271.x.
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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.
Per Rotbøll Nielsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Cesarean Section, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 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 11 Sep 2006. 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 Denmark. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00374504, which also lists 1 linked publication.
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 11 Sep 2006.