Vaginal ProlapsePhase 4NCT00769054
Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study
A Phase 4 study testing Ropivacaine and Isotonic NaCl in people with Vaginal Prolapse, 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 or placebo in patients undergoing repair of posterior vaginal wall prolapse. The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- Ropivacaine and Isotonic NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to Oct 2009
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eligible for elective repair of posterior vaginal wall prolapse
- able to speak and understand Danish
- able to give informed consent
Who cannot join
- alcohol or medical abuse
- allergies to local anesthetics
- age < 18 yrs.
- intolerance to opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie
The purpose of this study is to compare systematic local infiltration with ropivacaine or placebo in patients undergoing repair of posterior vaginal wall prolapse.
The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.
- Conditions
- Vaginal Prolapse
- Being tested
- Ropivacaine, Isotonic NaCl
- Keywords
- Postoperative pain, PONV
- Medical subject headings
- Uterine Prolapse, 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
Local Infiltration Analgesia with 1 % Ropivacaine
Isotonic NaClDrug
Local Infiltration with NaCl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Local Infiltration with Ropivacaine Receives: Drug: Ropivacaine |
| 2 | Placebo comparator | Local Infiltration with Placebo Receives: Drug: Isotonic NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain during rest, coughing and ambulation
Measured: ½, 1, 2, 4, 8, 12 and 24 h postoperatively
Secondary outcomes (1)
Postoperative Nausea and Vomitus
Measured: ½, 1, 2, 4, 8, 12 and 24 h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal ProlapseStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Billy B Kristensen, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769054
- Sponsor's protocol ID
- H-C-2008-035
- Status last verified
- Oct 2008
- First submitted
- 7 Oct 2008
- Last updated
- 9 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie
- ClinicalTrials.gov ID
- NCT00769054
- Acronym / sponsor ID
- H-C-2008-035
- Conditions
- Vaginal Prolapse
- Keywords
- Postoperative pain, PONV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Oct 2008 (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 or placebo in patients undergoing repair of posterior vaginal wall prolapse.
The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RopivacaineLocal Infiltration with Ropivacaine |
| 2 | Placebo comparator | Drug: Isotonic NaClLocal Infiltration with Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- eligible for elective repair of posterior vaginal wall prolapse
- 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 yrs.
- 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 |
|---|---|---|
| RopivacaineLocal Infiltration Analgesia with 1 % Ropivacaine | Drug | 1 |
| Isotonic NaClLocal Infiltration with NaCl | Drug | 2 |
Primary outcome
Postoperative Pain during rest, coughing and ambulation
Time frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively
1 secondary outcome
Postoperative Nausea and Vomitus
Time frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively
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 9 Jul 2010.
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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.
Billy B Kristensen, MD principal investigator
Hvidovre University Hospital
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 and Isotonic NaCl in people with Vaginal Prolapse, 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 9 Jul 2010. 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 during rest, coughing and ambulation (time frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively). 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 9 Jul 2010.