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Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples after total knee replacement

Condition or disease Intervention/treatment Phase
Metal Staple Removal After Total Knee Replacement Drug: Lidocaine patch Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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.
Drug: placebo
Placebo patch will be applied around the surgical wound about 20 minutes before removal of staples.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Complication rate of lidocaine patch [ Time Frame: Two weeks ]
    The incidence of related complications after application of lidocaine patch



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Males and females, aged 50-100 years
  2. The patients who undergo primary total knee replacement (performed by the same surgeon, Dr.Jiang)
  3. Clear consciousness
  4. No contraindication for staple removal on the post-operative day 7

Exclusion criteria:

  1. Allergy to lidocaine
  2. Patient with second or third degree atrio-ventricular block
  3. Patients with severe Sinoatrial node block
  4. Patients taking class I antiarrhythmia drugs
  5. Pregnant patients
  6. Patients undergoing revision total knee replacement
  7. Contraindication for removal of staples on post-operative day 7

Information from the National Library of Medicine

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


Contacts
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Contact: Tzu-Hao Tseng 886-978326537 b92401004@gmail.com
Contact: Ching-Chuan Jiang

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Test2, Taiwan, test3
Contact: Ching-Chuan Jiang    886-2-23123456 ext 65273    ccj@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ching-Chuan Jiang Department of Orthopedic Surgery, National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02812602    
Other Study ID Numbers: 201505116MINA
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by National Taiwan University Hospital:
Total Knee Replacement
Stitch
Removal
Pain
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action