Postoperative PainPhase 4NCT00864409
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty
A Phase 4 study testing ropivacaine 0,2% and saline.9% in people with Postoperative Pain and Hip Arthroplasty, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
High-volume infiltration analgesia may be effective in postoperative pain management following total hip arthroplasty. In this randomized, double-blind trial patients undergoing bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration in one hip and similar infiltration with saline… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Hip Arthroplasty
- What is being tested?
- ropivacaine 0,2% and saline.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- scheduled for bilateral total hip arthroplasty
- able to speak and understand Danish
Who cannot join
- treatment with opioids or steroids
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hviovre University Hospital
Hvidovre, DK-2650
Lasse Andersen, MD, +45 36323632, lasse.oestergaard.andersen@hvh.regionh.dk
About this study
High-volume infiltration analgesia may be effective in postoperative pain management following total hip arthroplasty. In this randomized, double-blind trial patients undergoing bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration in one hip and similar infiltration with saline (placebo) in the other hip.
- Conditions
- Postoperative Pain, Hip Arthroplasty
- Being tested
- ropivacaine 0,2%, saline.9%
- Keywords
- postoperative pain, total hip arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine 0,2%Drug
Local wound infiltrtation with 170 mL ropivacaine 2 mg/mL
saline.9%Drug
Wound infiltration with 170 mL sterile saline
| Study group | Role | What they receive |
|---|---|---|
| Hip 1 | Active comparator | high volume local anesthetic infiltration Receives: Drug: ropivacaine 0,2% |
| Hip 2 | Placebo comparator | Not described Receives: Drug: saline.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: 0-48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864409
- Sponsor's protocol ID
- KF-01-2006-4062
- Status last verified
- Mar 2009
- First submitted
- 17 Mar 2009
- Last updated
- 18 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00864409
- Acronym / sponsor ID
- KF-01-2006-4062
- Conditions
- Postoperative Pain, Hip Arthroplasty
- Keywords
- postoperative pain, total hip arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- First posted
- 18 Mar 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.
High-volume infiltration analgesia may be effective in postoperative pain management following total hip arthroplasty. In this randomized, double-blind trial patients undergoing bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration in one hip and similar infiltration with saline (placebo) in the other hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip 1 | Active comparator | Drug: ropivacaine 0,2%high volume local anesthetic infiltration |
| Hip 2 | Placebo comparator | Drug: saline.9% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled for bilateral total hip arthroplasty
- able to speak and understand Danish
Key exclusion criteria (1 listed)
- treatment with opioids or steroids
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 |
|---|---|---|
| ropivacaine 0,2%Local wound infiltrtation with 170 mL ropivacaine 2 mg/mL | Drug | Hip 1 |
| saline.9%Wound infiltration with 170 mL sterile saline | Drug | Hip 2 |
Primary outcome
postoperative pain
Time frame: 0-48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2009.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
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 0,2% and saline.9% in people with Postoperative Pain and Hip Arthroplasty, 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 2 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 18 Mar 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lasse Andersen, MD (+45 36323632, lasse.oestergaard.andersen@hvh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 0-48 hours postoperative). 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 18 Mar 2009.