Topical Lidocaine After Major Arthroscopic Knee Surgery
Topical Lidocaine Patch Does Not Have an Analgesic Effect After Major Arthroscopic Knee Surgery. A Double-blind Place-controlled Randomized Study
1 other identifier
interventional
21
1 country
1
Brief Summary
Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
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
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
January 13, 2012
CompletedApril 10, 2015
April 1, 2015
7 months
November 29, 2011
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Administration of analgesic drugs
Time for the first necessary administration of analgesic drugs.
24 hours
Secondary Outcomes (1)
Pain management after surgical treatment
24 hours
Study Arms (2)
Sham operation
PLACEBO COMPARATORKnee arthroscopic surgery
ACTIVE COMPARATORInterventions
A randomized group of patients received a placebo patch. As a supplement, each patient was given a dose of morphine, as required.
A randomized group of patients was given small patches with active 5% lidocaine.
Eligibility Criteria
You may qualify if:
- Patients who were planned for reconstruction of anterior crucial ligament, reconstruction of medial patellofemoral ligament and Elmslie-Trillat procedure for patella instability.
- Patients with synovectomies and menisci resection lasting more than 25 minutes.
- Patients \> 18 years
- Acceptance of informed consent
You may not qualify if:
- Patients with rheumatoid arthritis
- Patients with a Body Mass index of \> 35
- Patients who can not read and understand Danish
- Fertile women who does not use secure contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopaedic Surgery Research Unit, Aarhus University, Aalborg Hospital
Aalborg, 9000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sten Rasmussen, MD
Orthopaedic Research Unit, Aalborg University Hospital, Denmark
- PRINCIPAL INVESTIGATOR
Marthe Mari O. Bjerke, Stud.med.
Orthopaedic Research Unit, Aalborg University Hospital, Denmark
- PRINCIPAL INVESTIGATOR
Kirstine J. Bennedsgaard, Stud.med.
Orthopaedic Research Unit, Aalborg University Hospital, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2011
First Posted
January 13, 2012
Study Start
June 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
April 10, 2015
Record last verified: 2015-04