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Topical Lidocaine After Arthroscopy on Knee

Primary Purpose

Postoperative Pain, Topical Anaesthesia

Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Lidocaine adhesive tape
Adhesive tape
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Arthroscopy, Meniscus, Lidocaine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine adhesive tape

Adhesive tape

Arm Description

Outcomes

Primary Outcome Measures

Administration of analgesics or morphine in time
First time administration of analgesics or morphine in time on demand

Secondary Outcome Measures

Discharges of patients in time
Value Added Score (VAS) estimation of pain
Estimate pain at each administration of analgesics on demand before discharge of patients.

Full Information

First Posted
May 29, 2015
Last Updated
June 1, 2015
Sponsor
Northern Orthopaedic Division, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02460627
Brief Title
Topical Lidocaine After Arthroscopy on Knee
Official Title
Postoperative Pain Management With Topical Lidocaine After Arthroscopy on Knee. A Randomized Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Topical Anaesthesia
Keywords
Arthroscopy, Meniscus, Lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine adhesive tape
Arm Type
Experimental
Arm Title
Adhesive tape
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine adhesive tape
Intervention Description
700 mg for 12 hours
Intervention Type
Other
Intervention Name(s)
Adhesive tape
Intervention Description
For 12 hours
Primary Outcome Measure Information:
Title
Administration of analgesics or morphine in time
Description
First time administration of analgesics or morphine in time on demand
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Discharges of patients in time
Time Frame
1 day
Title
Value Added Score (VAS) estimation of pain
Description
Estimate pain at each administration of analgesics on demand before discharge of patients.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sten Rasmussen, M.D.
Phone
25520462
Ext
45
Email
sten.rasmussen@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Sofie S. Lang
Email
s.lang@rn.dk
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
State/Province
Region of Northern Jutland
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

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Topical Lidocaine After Arthroscopy on Knee

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