Topical Lidocaine After Arthroscopy on Knee
Postoperative Pain Management With Topical Lidocaine After Arthroscopy on Knee. A Randomized Double-blind Study
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 postoperative-pain
Started May 2015
Typical duration for phase_1 postoperative-pain
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
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJune 2, 2015
May 1, 2015
1.7 years
May 29, 2015
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Administration of analgesics or morphine in time
First time administration of analgesics or morphine in time on demand
1 day
Secondary Outcomes (2)
Discharges of patients in time
1 day
Value Added Score (VAS) estimation of pain
1 day
Study Arms (2)
Lidocaine adhesive tape
EXPERIMENTALAdhesive tape
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aalborg University Hospital
Aalborg, Region of Northern Jutland, 9000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 2, 2015
Study Start
May 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
June 2, 2015
Record last verified: 2015-05