Metal Staple Removal After Total Knee ReplacementNCT02812602
Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty
A study testing Lidocaine patch in people with Metal Staple Removal After Total Knee Replacement, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples after total knee replacement Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Metal Staple Removal After Total Knee Replacement
- What is being tested?
- Lidocaine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2016to Jun 2016
- 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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females, aged 50-100 years
- The patients who undergo primary total knee replacement (performed by the same surgeon, Dr.Jiang)
- Clear consciousness
- No contraindication for staple removal on the post-operative day 7
Who cannot join
- Allergy to lidocaine
- Patient with second or third degree atrio-ventricular block
- Patients with severe Sinoatrial node block
- Patients taking class I antiarrhythmia drugs
- Pregnant patients
- Patients undergoing revision total knee replacement
- Contraindication for removal of staples on post-operative day 7
Trial locations and contacts
1 site in 1 country.
Ching-Chuan Jiang contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Test2, test3
Ching-Chuan Jiang, 886-2-23123456 ext. 65273, ccj@ntu.edu.tw
About this study
Official title: Topical Anesthesia With Lidocaine Patch for Removal of Metal Staples After Total Knee Arthroplasty: A Prospective Randomized Trial
Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples after total knee replacement
Read the detailed description
This is a double-blind randomised control trial. After informed consent, the patients who undergoes primary total knee replacement will be assigned to either control group or experimental group randomly. The effectiveness and complication will be analysed.
If the patients are not medically fit for the study (including contraindications for lidocaine), they will be excluded.
- Being tested
- Lidocaine patch, placebo
- Keywords
- Total Knee Replacement, Stitch, Removal, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patchDrug
Lidocain patch will be applied around the surgical wound about 20 minutes before removal of staples.
placeboDrug
Placebo patch will be applied around the surgical wound about 20 minutes before removal of staples.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine patch | Experimental | The patients was randomly assigned to experimental group or placebo group. In this arm, lidocaine patches will be applied to the skin surrounding the surgical wound by one nurse practitioner. After more than 20 minutes the patch will be removed. Another nurse practitioner (double blinded) will remove the metal staples and record pain scale. Receives: Drug: Lidocaine patch |
| Placebo | Placebo comparator | The patients was randomly assigned to experimental group or placebo group. In this arm, a placebo patch will be applied to the skin surrounding the surgical wound by one nurse practitioner. After more than 20 minutes the patch will be removed. Another nurse practitioner (double blinded) will remove the metal staples and record pain scale. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale for pain
The person who removes the staples evaluated the pain intensity. The pain intensity is evaluated with visual analog scale for pain
Measured: 30min
Secondary outcomes (1)
Complication rate of lidocaine patch
The incidence of related complications after application of lidocaine patch
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metal Staple Removal After Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Chuan Jiang, Principal investigator, Department of Orthopedic Surgery, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812602
- Sponsor's protocol ID
- 201505116MINA
- Status last verified
- Jun 2016
- First submitted
- 17 Apr 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Anesthesia With Lidocaine Patch for Removal of Metal Staples After Total Knee Arthroplasty: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02812602
- Acronym / sponsor ID
- 201505116MINA
- Keywords
- Total Knee Replacement, Stitch, Removal, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 24 Jun 2016 (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.
Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples after total knee replacement
Detailed description
This is a double-blind randomised control trial. After informed consent, the patients who undergoes primary total knee replacement will be assigned to either control group or experimental group randomly. The effectiveness and complication will be analysed.
If the patients are not medically fit for the study (including contraindications for lidocaine), they will be excluded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine patch | Experimental | Drug: Lidocaine patchThe patients was randomly assigned to experimental group or placebo group. In this arm, lidocaine patches will be applied to the skin surrounding the surgical wound by one nurse practitioner. After more than 20 minutes the patch will be removed. Another nurse practitioner (double blinded) will remove the metal staples and record pain scale. |
| Placebo | Placebo comparator | Drug: placeboThe patients was randomly assigned to experimental group or placebo group. In this arm, a placebo patch will be applied to the skin surrounding the surgical wound by one nurse practitioner. After more than 20 minutes the patch will be removed. Another nurse practitioner (double blinded) will remove the metal staples and record pain scale. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, aged 50-100 years
- The patients who undergo primary total knee replacement (performed by the same surgeon, Dr.Jiang)
- Clear consciousness
- No contraindication for staple removal on the post-operative day 7
Key exclusion criteria (7 listed)
- Allergy to lidocaine
- Patient with second or third degree atrio-ventricular block
- Patients with severe Sinoatrial node block
- Patients taking class I antiarrhythmia drugs
- Pregnant patients
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 patchLidocain patch will be applied around the surgical wound about 20 minutes before removal of staples. | Drug | Lidocaine patch |
| placeboPlacebo patch will be applied around the surgical wound about 20 minutes before removal of staples. | Drug | Placebo |
Primary outcome
Visual analog scale for pain
Time frame: 30min
The person who removes the staples evaluated the pain intensity. The pain intensity is evaluated with visual analog scale for pain
1 secondary outcome
Complication rate of lidocaine patch
Time frame: Two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Individual participant dataSharing planned: Undecided
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.
Ching-Chuan Jiang contact
Ching-Chuan Jiang principal investigator
Department of Orthopedic Surgery, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine patch in people with Metal Staple Removal After Total Knee Replacement, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 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 24 Jun 2016. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Hao Tseng (886-978326537, b92401004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale for pain (time frame: 30min). 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 24 Jun 2016.