Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty

June 21, 2016 updated by: National Taiwan University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Test2
      • Taipei, Test2, Taiwan, test3
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Ching-Chuan Jiang
          • Phone Number: 65273 886-2-23123456
          • Email: ccj@ntu.edu.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30min

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Ching-Chuan Jiang, Department of Orthopedic Surgery, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2016

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

April 17, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (ESTIMATE)

June 24, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201505116MINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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