Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty

National Taiwan University

Status: Unknown

Conditions: Metal Staple Removal After Total Knee Replacement

Treatments: Drug: Lidocaine patch; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02812602

201505116MINA

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Lidocaine patch

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine patch

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo