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Topical Lidocaine After Arthroscopy on Knee

N

Northern Orthopaedic Division, Denmark

Status and phase

Unknown
Phase 1

Conditions

Postoperative Pain
Topical Anaesthesia

Treatments

Other: Adhesive tape
Drug: Lidocaine adhesive tape

Study type

Interventional

Funder types

Other

Identifiers

NCT02460627
N-20150006

Details and patient eligibility

About

More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the knee. Walking function and physical activities are affected by this intensive pain although local anaesthetic is given in the joint and soft tissue.

The patients are often discharged on the same day as the arthroscopy takes place depending on their ability to walk with or without assistive technology.

It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice pack on a painful knee to reduce pain intensity. The aim of the project is to study whether pain intensity and analgesics can be additionally reduced by giving local anaesthetic by means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice pack on a painful knee.

The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous fold removed surgically.

This study is planned to be a pilot study in order to complete a future large medical science study.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Planned resection of meniscus (DS832, DM232)
  • Planned meniscus suture (DS832)
  • Planned plica resection (DM659)
  • Patients >=18 years and <50 years
  • Statement of consent
  • Tolerance to Lidocaine (analgesics)

Exclusion criteria

  • Type 1 diabetes or type 2 diabetes
  • Allergic to Lidocaine (analgesics)
  • Heart disease, liver disease, kidney disease
  • BMI >=35
  • Unability to read or speak Danish
  • Rheumatoid arthritis or other degenerative diseases in joint, bone structure or cartilage
  • Insufficient coagulation
  • Medication of morphine pre-operatively
  • Pregnant and nursing women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 2 patient groups, including a placebo group

Lidocaine adhesive tape
Experimental group
Treatment:
Drug: Lidocaine adhesive tape
Adhesive tape
Placebo Comparator group
Treatment:
Other: Adhesive tape

Trial contacts and locations

1

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Central trial contact

Sofie S. Lang; Sten Rasmussen, M.D.

Data sourced from clinicaltrials.gov

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