Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty
Topical Anesthesia With Lidocaine Patch for Removal of Metal Staples After Total Knee Arthroplasty: A Prospective Randomized Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples after total knee replacement
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedJune 24, 2016
June 1, 2016
2 months
April 17, 2016
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Complication rate of lidocaine patch
Two weeks
Study Arms (2)
Lidocaine patch
EXPERIMENTALThe 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 COMPARATORThe 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.
Interventions
Lidocain patch will be applied around the surgical wound about 20 minutes before removal of staples.
Placebo patch will be applied around the surgical wound about 20 minutes before removal of staples.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Test2, test3, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching-Chuan Jiang
Department of Orthopedic Surgery, National Taiwan University Hospital
Central Study Contacts
Ching-Chuan Jiang
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2016
First Posted
June 24, 2016
Study Start
April 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 24, 2016
Record last verified: 2016-06