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Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples after total knee replacement
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine patch | Drug | Lidocain patch will be applied around the surgical wound about 20 minutes before removal of staples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30min |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate of lidocaine patch | The incidence of related complications after application of lidocaine patch | Two weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tzu-Hao Tseng | Contact | 886-978326537 | b92401004@gmail.com | |
| Ching-Chuan Jiang | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Ching-Chuan Jiang | Department of Orthopedic Surgery, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Test2 | test3 | Taiwan |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| placebo | Drug | Placebo patch will be applied around the surgical wound about 20 minutes before removal of staples. |
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