Pain, PostoperativePhase 4NCT00891540
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section
A Phase 4 study testing Ropivacaine in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section. The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pain, Postoperative, Postoperative Nausea and Vomiting, Cesarean Section
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2009to May 2010
- 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
- No healthy volunteers
- Adult
Who may be able to join
- eligible for elective caesarean section
- able to speak and understand Danish
- able to give informed consent
Who cannot join
- alcohol or medical abuse
- allergies to local anesthetics
- age < 18 years
- intolerance to opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.
The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.
The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption.
- Being tested
- Ropivacaine, placebo
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Ropivacaine 0.5%
RopivacaineDrug
Ropivacaine 0.2%
placeboDrug
Isotonic NaCl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Local infiltration with Ropivacaine Receives: Drug: Ropivacaine |
| 2 | Active comparator | Local infiltration with Ropivacaine Receives: Drug: Ropivacaine |
| 3 | Placebo comparator | Local infiltration with NaCl Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Measured: 24 hours
Secondary outcomes (1)
Postoperative nausea and vomiting (PONV)
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 posted1 May 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891540
- Sponsor's protocol ID
- H-C-2009-019
- Status last verified
- Apr 2009
- First submitted
- 30 Apr 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.
- ClinicalTrials.gov ID
- NCT00891540
- Acronym / sponsor ID
- H-C-2009-019
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 May 2009 (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 purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.
The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RopivacaineLocal infiltration with Ropivacaine |
| 2 | Active comparator | Drug: RopivacaineLocal infiltration with Ropivacaine |
| 3 | Placebo comparator | Drug: placeboLocal infiltration with NaCl |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- eligible for elective caesarean section
- able to speak and understand Danish
- able to give informed consent
Key exclusion criteria (4 listed)
- alcohol or medical abuse
- allergies to local anesthetics
- age < 18 years
- intolerance to opioids
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 |
|---|---|---|
| RopivacaineRopivacaine 0.5% | Drug | 1 |
| RopivacaineRopivacaine 0.2% | Drug | 2 |
| placeboIsotonic NaCl | Drug | 3 |
Primary outcome
Postoperative pain
Time frame: 24 hours
1 secondary outcome
Postoperative nausea and vomiting (PONV)
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 23 Jun 2011.
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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 4 study testing Ropivacaine in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Hvidovre University Hospital 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 3 inclusion and 4 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 Jun 2011. 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. 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 (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 23 Jun 2011.