Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Topical Anesthesia With Lidocaine Patch for Removal of Metal Staples After Total Knee Arthroplasty: A Prospective Randomized Trial

Conditions
-----------------
Metal Staple Removal After Total Knee Replacement

Intervention / Treatment
-----------------
* Drug: Lidocaine patch
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 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 Exclusion criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine patch<br>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. | Drug: Lidocaine patch<br>* Lidocain patch will be applied around the surgical wound about 20 minutes before removal of staples.<br>|
| Placebo Comparator: Placebo<br>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. | Drug: placebo<br>* Placebo patch will be applied around the surgical wound about 20 minutes before removal of staples.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate of lidocaine patch | The incidence of related complications after application of lidocaine patch | Two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Knee Replacement, Stitch, Removal, Pain