Postoperative PainPhase 4NCT01012232
Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration
A Phase 4 study testing 20 mL ropivacaine 5 mg/mL and 10 mL ropivacaine 10 mg/mL in people with Postoperative Pain and Analgesic Efficacy, run by Lundbeck Foundation at 1 site in Denmark.
Trial summary
In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Analgesic Efficacy
- What is being tested?
- 20 mL ropivacaine 5 mg/mL and 10 mL ropivacaine 10 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scheduled for total knee arthroplasty
- Able to give informed oral and written consent to participate
Who cannot join
- Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases
- History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.)
- Allergies to any of the drugs administered.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Lundbeck Centre for fast-track hip and knee arthroplasty
Copenhagen
About this study
Official title: The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.
In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.
- Conditions
- Postoperative Pain, Analgesic Efficacy
- Being tested
- 20 mL ropivacaine 5 mg/mL, 10 mL ropivacaine 10 mg/mL
- Keywords
- total knee arthroplasty, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mL ropivacaine 5 mg/mLDrug
10 mL ropivacaine 10 mg/mLDrug
| Study group | Role | What they receive |
|---|---|---|
| low volume local anesthetic | Active comparator | bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL) Receives: Drug: 10 mL ropivacaine 10 mg/mL |
| high volume local anesthetic | Experimental | bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) Receives: Drug: 20 mL ropivacaine 5 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: 32 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startJun 2009
- 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 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
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundbeck Foundation
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012232
- Sponsor's protocol ID
- H-D-2009-016
- Status last verified
- Nov 2009
- First submitted
- 10 Nov 2009
- Last updated
- 11 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.
- ClinicalTrials.gov ID
- NCT01012232
- Acronym / sponsor ID
- H-D-2009-016
- Conditions
- Postoperative Pain, Analgesic Efficacy
- Keywords
- total knee arthroplasty, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Lundbeck FoundationUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Nov 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.
In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low volume local anesthetic | Active comparator | Drug: 10 mL ropivacaine 10 mg/mLbolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL) |
| high volume local anesthetic | Experimental | Drug: 20 mL ropivacaine 5 mg/mLbolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for total knee arthroplasty
- Able to give informed oral and written consent to participate
Key exclusion criteria (3 listed)
- Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases
- History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.)
- Allergies to any of the drugs administered.
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 |
|---|---|---|
| 20 mL ropivacaine 5 mg/mL | Drug | high volume local anesthetic |
| 10 mL ropivacaine 10 mg/mL | Drug | low volume local anesthetic |
Primary outcome
postoperative pain
Time frame: 32 hours postoperative
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 Nov 2009.
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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 20 mL ropivacaine 5 mg/mL and 10 mL ropivacaine 10 mg/mL in people with Postoperative Pain and Analgesic Efficacy, run by Lundbeck Foundation 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 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 Nov 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. 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: 32 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 11 Nov 2009.