Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT02812602|
Recruitment Status : Unknown
Verified June 2016 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metal Staple Removal After Total Knee Replacement||Drug: Lidocaine patch Drug: placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Topical Anesthesia With Lidocaine Patch for Removal of Metal Staples After Total Knee Arthroplasty: A Prospective Randomized Trial|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Experimental: Lidocaine patch
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
Lidocain patch will be applied around the surgical wound about 20 minutes before removal of staples.
Placebo Comparator: Placebo
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.
Placebo patch will be applied around the surgical wound about 20 minutes before removal of staples.
- 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
- Complication rate of lidocaine patch [ Time Frame: Two weeks ]The incidence of related complications after application of lidocaine patch
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812602
|Contact: Tzu-Hao Tsengfirstname.lastname@example.org|
|Contact: Ching-Chuan Jiang|
|National Taiwan University Hospital||Recruiting|
|Taipei, Test2, Taiwan, test3|
|Contact: Ching-Chuan Jiang 886-2-23123456 ext 65273 email@example.com|
|Principal Investigator:||Ching-Chuan Jiang||Department of Orthopedic Surgery, National Taiwan University Hospital|