Arthroplasty, Replacement, KneePhase 4NCT00421967
Postoperative Analgesia After Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine, Ketorolac, adrenaline and Ropivacaine Ketorolac in people with Arthroplasty, Replacement, Knee, run by University of Aarhus at 1 site in Denmark.
Trial summary
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Ropivacaine, Ketorolac, adrenaline and Ropivacaine Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Apr 2008
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted consecutively to primary total knee arthroplasty.
- Provided informed consent
Who cannot join
- Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception
- Severe chronic neurogenic pain
- Medical treated diabetes
- Contraindications for spinal aesthesia and epidural analgesia
- Known hypersensitivity towards study drugs
- Rheumatoid arthritis
Show all 11Show fewer
- Treatment with narcotics
- Treatment with antidepressants
- Severe obesity BMI>35
- Treatment with antacid
- Not able to speak and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization.
The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Ropivacaine, Ketorolac, adrenaline, Ropivacaine Ketorolac
- Keywords
- 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.
Ropivacaine, Ketorolac, adrenalineDrug
Infiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac
Ropivacaine KetorolacDrug
Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Ropivacaine, Ketorolac, adrenaline |
| 2 | Active comparator | Not described Receives: Drug: Ropivacaine Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgésia consumption
Measured: 48 h
Secondary outcomes (4)
Time to discharge
Cytokine level
Measured: 48 h
Pain scores VAS
Measured: 72 h
Side-effects
Measured: 72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionApr 2008
Why it stopped: Interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Birgitte V Christensen, M.D., Principal investigator, Glostrup Hospital, Glostrup 2600, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421967
- Sponsor's protocol ID
- 2006-004638-33.
- Status last verified
- May 2008
- First submitted
- 12 Jan 2007
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion
- ClinicalTrials.gov ID
- NCT00421967
- Acronym / sponsor ID
- 2006-004638-33.
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 15 Jan 2007 (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.
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization.
The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ropivacaine, Ketorolac, adrenaline |
| 2 | Active comparator | Drug: Ropivacaine Ketorolac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted consecutively to primary total knee arthroplasty.
- Provided informed consent
Key exclusion criteria (11 listed)
- Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception
- Severe chronic neurogenic pain
- Medical treated diabetes
- Contraindications for spinal aesthesia and epidural analgesia
- Known hypersensitivity towards study drugs
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, Ketorolac, adrenalineInfiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac | Drug | 1 |
| Ropivacaine KetorolacEpidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg | Drug | 2 |
Primary outcome
Analgésia consumption
Time frame: 48 h
4 secondary outcomes
Time to discharge
Cytokine level
Time frame: 48 h
Pain scores VAS
Time frame: 72 h
Side-effects
Time frame: 72 h
Results and safety
The study was stopped early (reason given: Interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
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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.
Birgitte V Christensen, M.D. principal investigator
Glostrup Hospital, Glostrup 2600, Denmark
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, Ketorolac, adrenaline and Ropivacaine Ketorolac in people with Arthroplasty, Replacement, Knee, run by University of Aarhus 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 11 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: stopped early, as of the sponsor's last update on 7 May 2008. 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 was stopped early (reason given: Interim analysis). Results are not available in the source record.
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?
Analgésia consumption (time frame: 48 h). 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 7 May 2008.