Postoperative PainPhase 1NCT02460627
Topical Lidocaine After Arthroscopy on Knee
A Phase 1 study testing Lidocaine adhesive tape and Adhesive tape in people with Postoperative Pain and Topical Anaesthesia, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the knee. Walking function and physical activities are affected by this intensive pain although local anaesthetic is given in the joint and soft tissue. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Postoperative Pain, Topical Anaesthesia
- What is being tested?
- Lidocaine adhesive tape and Adhesive tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to Jan 2017
- Phase
- Phase 1
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Planned resection of meniscus (DS832, DM232)
- Planned meniscus suture (DS832)
- Planned plica resection (DM659)
- Patients >=18 years and <50 years
- Statement of consent
- Tolerance to Lidocaine (analgesics)
Who cannot join
- Type 1 diabetes or type 2 diabetes
- Allergic to Lidocaine (analgesics)
- Heart disease, liver disease, kidney disease
- BMI >=35
- Unability to read or speak Danish
- Rheumatoid arthritis or other degenerative diseases in joint, bone structure or cartilage
Show all 9Show fewer
- Insufficient coagulation
- Medication of morphine pre-operatively
- Pregnant and nursing women
Trial locations and contacts
1 site in 1 country.
Sofie S. Lang contact
Denmark1 site
Aalborg University Hospital
Aalborg, Region of Northern Jutland, 9000
About this study
Official title: Postoperative Pain Management With Topical Lidocaine After Arthroscopy on Knee. A Randomized Double-blind Study
More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the knee. Walking function and physical activities are affected by this intensive pain although local anaesthetic is given in the joint and soft tissue.
The patients are often discharged on the same day as the arthroscopy takes place depending on their ability to walk with or without assistive technology.
Read more
It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice pack on a painful knee to reduce pain intensity. The aim of the project is to study whether pain intensity and analgesics can be additionally reduced by giving local anaesthetic by means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice pack on a painful knee.
The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous fold removed surgically.
This study is planned to be a pilot study in order to complete a future large medical science study.
- Conditions
- Postoperative Pain, Topical Anaesthesia
- Being tested
- Lidocaine adhesive tape, Adhesive tape
- Keywords
- Arthroscopy, Meniscus, Lidocaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine adhesive tapeDrug
700 mg for 12 hours
Adhesive tapeOther
For 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine adhesive tape | Experimental | Not described Receives: Drug: Lidocaine adhesive tape |
| Adhesive tape | Placebo comparator | Not described Receives: Other: Adhesive tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administration of analgesics or morphine in time
First time administration of analgesics or morphine in time on demand
Measured: 1 day
Secondary outcomes (2)
Discharges of patients in time
Measured: 1 day
Value Added Score (VAS) estimation of pain
Estimate pain at each administration of analgesics on demand before discharge of patients.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460627
- Sponsor's protocol ID
- N-20150006
- Status last verified
- May 2015
- First submitted
- 29 May 2015
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management With Topical Lidocaine After Arthroscopy on Knee. A Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT02460627
- Acronym / sponsor ID
- N-20150006
- Conditions
- Postoperative Pain, Topical Anaesthesia
- Keywords
- Arthroscopy, Meniscus, Lidocaine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 2 Jun 2015 (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.
More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the knee. Walking function and physical activities are affected by this intensive pain although local anaesthetic is given in the joint and soft tissue.
The patients are often discharged on the same day as the arthroscopy takes place depending on their ability to walk with or without assistive technology.
It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice pack on a painful knee to reduce pain intensity. The aim of the project is to study whether pain intensity and analgesics can be additionally reduced by giving local anaesthetic by means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice pack on a painful knee.
The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous fold removed surgically.
This study is planned to be a pilot study in order to complete a future large medical science study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine adhesive tape | Experimental | Drug: Lidocaine adhesive tape |
| Adhesive tape | Placebo comparator | Other: Adhesive tape |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Planned resection of meniscus (DS832, DM232)
- Planned meniscus suture (DS832)
- Planned plica resection (DM659)
- Patients >=18 years and <50 years
- Statement of consent
Key exclusion criteria (9 listed)
- Type 1 diabetes or type 2 diabetes
- Allergic to Lidocaine (analgesics)
- Heart disease, liver disease, kidney disease
- BMI >=35
- Unability to read or speak Danish
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 |
|---|---|---|
| Lidocaine adhesive tape700 mg for 12 hours | Drug | Lidocaine adhesive tape |
| Adhesive tapeFor 12 hours | Other | Adhesive tape |
Primary outcome
Administration of analgesics or morphine in time
Time frame: 1 day
First time administration of analgesics or morphine in time on demand
2 secondary outcomes
Discharges of patients in time
Time frame: 1 day
Value Added Score (VAS) estimation of pain
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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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.
Sofie S. Lang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine adhesive tape and Adhesive tape in people with Postoperative Pain and Topical Anaesthesia, 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 6 inclusion and 9 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 2 Jun 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Sten Rasmussen, M.D. (25520462 ext. 45, sten.rasmussen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Administration of analgesics or morphine in time (time frame: 1 day). 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 2 Jun 2015; AzTrials last refreshed its copy on 31 Oct 2026.