Postoperative Pain ManagementPhase 4NCT01726686
Pain Treatment After TKA With LIA and Intra-articular Continuous Infusion Pump
A Phase 4 study testing Ropivacaine in people with Postoperative Pain Management, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the effect on postoperative pain and function by adding intraarticular continuous infusion pump with local anesthetic after total knee arthroplasty where local infiltration analgesia has already been given. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2010to Apr 2014
- 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
- Primary osteoarthritis of the knee necessitating total knee replacement
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up
Who cannot join
- Known allergy to local anaesthetics or other contraindication for the use of local anaesthetics.
- Treatment with Warfarin.
- Bilateral operation
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopedics, Skane University Hospital, Lund University
Lund
About this study
Official title: Evaluation of Intra-articular Continuous Infusion Pump With Ropivacaine in Addition to Local Infiltration Analgesia (LIA) in Total Knee Arthroplasty (TKA). A Placebo Controlled Randomised Trial.
The purpose of this study is to evaluate the effect on postoperative pain and function by adding intraarticular continuous infusion pump with local anesthetic after total knee arthroplasty where local infiltration analgesia has already been given.
Read the detailed description
200 patients with osteoarthritis (OA) of the knee necessitating total knee arthroplasty are entered into the study. All patients are given a standard protocol of analgesics pre- and postoperatively. All patients get periarticular LIA-injection (150 ml) with a total of 300 mg Ropivacaine, 30 mg Toradol and 0.5 mg Adrenalin. In the end of the operation all patients get an epidural type of catheter intraarticular with a coupled continuous infusion pump that delivers 2 ml per hour and are disconnected after 48 hours. The University hospital pharmacy has prepared 200 pumps; 100 Active substance pumps with 100 ml Ropivacaine (10mg/ml) and 100 placebo pumps with 100 ml sodium chloride (NaCl). All patients are by computer software randomized to receive either active or placebo pump. Only one nurse, not involved in neither the operation nor the after treatment, has the key to what substance it is in the numbered pumps. Thus, it is a double blinded trial during the whole follow up period. Before the operation the patients are asked to fill out a knee specific outcome questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), and a general outcome questionnaire, the Euroqol (EQ-5D), and the knee range of motion is measured by a physiotherapist. After the operation the patients are monitored at the ward by the nurses and physiotherapists. The level of pain is measured twice daily (noon and 8 PM) according to the Visual-Analog-Scale (VAS). The range of motion and is measured on day 4 and at the day 14 and day 30 follow up. The number of days the patients need to stay in hospital after operation are registered. The amount of extra doses of analgesics the patient requires are registered as well as the complications (illness, wound problems, infections etc). The patients are to be followed clinically for 2 years as well as with outcome questionnaires.
- Conditions
- Postoperative Pain Management
- Being tested
- Ropivacaine, Placebo
- Keywords
- Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin, Narop
100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine in the pump | Active comparator | The intra-articular Continuous Infusion Pump is filled with Ropivacaine,10 mg/ml, set at 2 ml/hour for 48 hours postoperatively. Receives: Drug: Ropivacaine |
| Placebo in the pump | Placebo comparator | The intra-articular Continuous Infusion Pump is filled with NaCl, set at 2 ml/hour for 48 hours postoperatively. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative pain
The patient are asked to grade their pain on a VAS-scale (0-100)twice daily for the first 4 days after the TKA operation and at the 2 weeks follow-up. Changes in pain during this time frame are recorded to see if there are any differences between the two groups.
Measured: The first 4 postoperative days at noon and 8 PM
Secondary outcomes (1)
Extra oral analgesia consumption
All extra analgesia consumption are noted during the first 4 postoperative days. All patients have a standard pain management medication (depending on weight, age and sex) and only extra doses are noted.
Measured: First 4 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunnar Flivik, Region Skane
- Investigators
- Gunnar Flivik, MD PhD, Principal investigator, Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726686
- Sponsor's protocol ID
- LIA-Pump_AA
- Status last verified
- Nov 2014
- First submitted
- 30 Oct 2012
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intra-articular Continuous Infusion Pump With Ropivacaine in Addition to Local Infiltration Analgesia (LIA) in Total Knee Arthroplasty (TKA). A Placebo Controlled Randomised Trial.
- ClinicalTrials.gov ID
- NCT01726686
- Acronym / sponsor ID
- LIA-Pump_AA
- Conditions
- Postoperative Pain Management
- Keywords
- Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Nov 2012 (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 evaluate the effect on postoperative pain and function by adding intraarticular continuous infusion pump with local anesthetic after total knee arthroplasty where local infiltration analgesia has already been given.
Detailed description
200 patients with osteoarthritis (OA) of the knee necessitating total knee arthroplasty are entered into the study. All patients are given a standard protocol of analgesics pre- and postoperatively. All patients get periarticular LIA-injection (150 ml) with a total of 300 mg Ropivacaine, 30 mg Toradol and 0.5 mg Adrenalin. In the end of the operation all patients get an epidural type of catheter intraarticular with a coupled continuous infusion pump that delivers 2 ml per hour and are disconnected after 48 hours. The University hospital pharmacy has prepared 200 pumps; 100 Active substance pumps with 100 ml Ropivacaine (10mg/ml) and 100 placebo pumps with 100 ml sodium chloride (NaCl). All patients are by computer software randomized to receive either active or placebo pump. Only one nurse, not involved in neither the operation nor the after treatment, has the key to what substance it is in the numbered pumps. Thus, it is a double blinded trial during the whole follow up period. Before the operation the patients are asked to fill out a knee specific outcome questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), and a general outcome questionnaire, the Euroqol (EQ-5D), and the knee range of motion is measured by a physiotherapist. After the operation the patients are monitored at the ward by the nurses and physiotherapists. The level of pain is measured twice daily (noon and 8 PM) according to the Visual-Analog-Scale (VAS). The range of motion and is measured on day 4 and at the day 14 and day 30 follow up. The number of days the patients need to stay in hospital after operation are registered. The amount of extra doses of analgesics the patient requires are registered as well as the complications (illness, wound problems, infections etc). The patients are to be followed clinically for 2 years as well as with outcome questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine in the pump | Active comparator | Drug: RopivacaineThe intra-articular Continuous Infusion Pump is filled with Ropivacaine,10 mg/ml, set at 2 ml/hour for 48 hours postoperatively. |
| Placebo in the pump | Placebo comparator | Drug: PlaceboThe intra-articular Continuous Infusion Pump is filled with NaCl, set at 2 ml/hour for 48 hours postoperatively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primary osteoarthritis of the knee necessitating total knee replacement
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up
Key exclusion criteria (3 listed)
- Known allergy to local anaesthetics or other contraindication for the use of local anaesthetics.
- Treatment with Warfarin.
- Bilateral operation
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 |
|---|---|---|
| RopivacaineAlso: Naropin, Narop100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour | Drug | Ropivacaine in the pump |
| Placebo | Drug | Placebo in the pump |
Primary outcome
Change in postoperative pain
Time frame: The first 4 postoperative days at noon and 8 PM
The patient are asked to grade their pain on a VAS-scale (0-100)twice daily for the first 4 days after the TKA operation and at the 2 weeks follow-up. Changes in pain during this time frame are recorded to see if there are any differences between the two groups.
1 secondary outcome
Extra oral analgesia consumption
Time frame: First 4 postoperative days
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 26 Nov 2014.
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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.
Gunnar Flivik, MD PhD principal investigator
Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
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 Postoperative Pain Management, run by Region Skane at 1 site in Sweden.
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 26 Nov 2014. 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 Sweden. 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?
Change in postoperative pain (time frame: The first 4 postoperative days at noon and 8 PM). 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 26 Nov 2014.