Fracture of PatellaNCT01509729
Topical Lidocaine After Major Arthroscopic Knee Surgery
A study testing Knee arthroscopic surgery in people with Fracture of Patella and Pain, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Patella, Pain
- What is being tested?
- Knee arthroscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Jan 2012
- Phase
- Interventional
- 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 who were planned for reconstruction of anterior crucial ligament, reconstruction of medial patellofemoral ligament and Elmslie-Trillat procedure for patella instability.
- Patients with synovectomies and menisci resection lasting more than 25 minutes.
- Patients > 18 years
- Acceptance of informed consent
Who cannot join
- Patients with rheumatoid arthritis
- Patients with a Body Mass index of > 35
- Patients who can not read and understand Danish
- Fertile women who does not use secure contraception
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Surgery Research Unit, Aarhus University, Aalborg Hospital
Aalborg, 9000
About this study
Official title: Topical Lidocaine Patch Does Not Have an Analgesic Effect After Major Arthroscopic Knee Surgery. A Double-blind Place-controlled Randomized Study
Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic treatment.
Read the detailed description
Lidocaine is well-known as analgesic treatment on skin and hypodermic veins. Since 1996 it has been documented that topical lidocaine has an analgesic effect 24 hours after surgical treatment.
The aim is to determine a possible reduction in pain after knee arthroscopy with topical lidocaine.
- Conditions
- Fracture of Patella, Pain
- Being tested
- Sham operation, Knee arthroscopic surgery
- Keywords
- Knee, Arthroscopy, Lidocaine patch, Pain management after knee arthroscopy
- Medical subject headings
- Patella Fracture, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham operationProcedure or surgery
Also called Knee soft-tissue
A randomized group of patients received a placebo patch. As a supplement, each patient was given a dose of morphine, as required.
Knee arthroscopic surgeryProcedure or surgery
Also called Knee soft-tissue
A randomized group of patients was given small patches with active 5% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Sham operation | Placebo comparator | Not described Receives: Procedure: Sham operation |
| Knee arthroscopic surgery | Active comparator | Not described Receives: Procedure: Knee arthroscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administration of analgesic drugs
Time for the first necessary administration of analgesic drugs.
Measured: 24 hours
Secondary outcomes (1)
Pain management after surgical treatment
The intake of necessary analgesic drugs after 6, 12, 18 and 24 hours after surgical treatment.
Pain score according to the VAS scale when the patients rest and make movements.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJun 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of PatellaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, MD, Study chair, Orthopaedic Research Unit, Aalborg University Hospital, DenmarkMarthe Mari O. Bjerke, Stud.med., Principal investigator, Orthopaedic Research Unit, Aalborg University Hospital, DenmarkKirstine J. Bennedsgaard, Stud.med., Principal investigator, Orthopaedic Research Unit, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509729
- Sponsor's protocol ID
- N-20110028
- Status last verified
- Apr 2015
- First submitted
- 29 Nov 2011
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Lidocaine Patch Does Not Have an Analgesic Effect After Major Arthroscopic Knee Surgery. A Double-blind Place-controlled Randomized Study
- ClinicalTrials.gov ID
- NCT01509729
- Acronym / sponsor ID
- N-20110028
- Conditions
- Fracture of Patella, Pain
- Keywords
- Knee, Arthroscopy, Lidocaine patch, Pain management after knee arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Jan 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.
Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic treatment.
Detailed description
Lidocaine is well-known as analgesic treatment on skin and hypodermic veins. Since 1996 it has been documented that topical lidocaine has an analgesic effect 24 hours after surgical treatment.
The aim is to determine a possible reduction in pain after knee arthroscopy with topical lidocaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham operation | Placebo comparator | Procedure: Sham operation |
| Knee arthroscopic surgery | Active comparator | Procedure: Knee arthroscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who were planned for reconstruction of anterior crucial ligament, reconstruction of medial patellofemoral ligament and Elmslie-Trillat procedure for patella instability.
- Patients with synovectomies and menisci resection lasting more than 25 minutes.
- Patients > 18 years
- Acceptance of informed consent
Key exclusion criteria (4 listed)
- Patients with rheumatoid arthritis
- Patients with a Body Mass index of > 35
- Patients who can not read and understand Danish
- Fertile women who does not use secure contraception
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 |
|---|---|---|
| Sham operationAlso: Knee soft-tissueA randomized group of patients received a placebo patch. As a supplement, each patient was given a dose of morphine, as required. | Procedure or surgery | Sham operation |
| Knee arthroscopic surgeryAlso: Knee soft-tissueA randomized group of patients was given small patches with active 5% lidocaine. | Procedure or surgery | Knee arthroscopic surgery |
Primary outcome
Administration of analgesic drugs
Time frame: 24 hours
Time for the first necessary administration of analgesic drugs.
1 secondary outcome
Pain management after surgical treatment
Time frame: 24 hours
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 10 Apr 2015.
Related trials for Fracture of Patella
Active, not recruiting
Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial
Patella Fracture
Not yet recruiting
Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia
Anterior Cruciate Ligament Injury, Patellofemoral Pain Syndrome
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
RecruitingObservational study
Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
Osteochondral Defect, Osteochondritis Dissecans
Active, not recruiting
Study of Knee Replacements for Patellofemoral Osteoarthritis
Osteoarthritis, Knee, Patellofemoral Knee Arthroplasty
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.
Sten Rasmussen, MD study chair
Orthopaedic Research Unit, Aalborg University Hospital, Denmark
Marthe Mari O. Bjerke, Stud.med. principal investigator
Orthopaedic Research Unit, Aalborg University Hospital, Denmark
Kirstine J. Bennedsgaard, Stud.med. principal investigator
Orthopaedic Research Unit, Aalborg University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee arthroscopic surgery in people with Fracture of Patella and Pain, run by Northern Orthopaedic Division, Denmark 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 4 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 10 Apr 2015. 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.
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?
Administration of analgesic drugs (time frame: 24 hours). 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 10 Apr 2015.