- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01279447
Infrapatellar Nerve Block for Post-operative Knee Arthroscopy Pain Control
April 14, 2014 updated by: Larry Hsu, Northwestern University
Infrapatellar Nerve Block for Post-operative Analgesia for Knee Arthroscopy
The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy.
Randomized, double-blinded, placebo controlled, study.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Olson Surgical Pavilion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- planned knee arthroscopy with soft tissue intervention
- age 18+
- English speaking
Exclusion Criteria:
- contraindications to nerve block: eg neuropathy, type 1 diabetes, coagulopathy
- knee arthroscopy with planned bony intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: Placebo
A sham infrapatellar block performed under US guidance with normal saline
|
10cc, single dose, US guided injection
Other Names:
|
EXPERIMENTAL: Infrapatellar nerve block
An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
|
10cc, single dose, US guided injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post op Pain Score
Time Frame: 0 hours
|
immediate postop pain score, Visual Analog Scale.
Evaluates pain on scale from 0-10.
0=no pain.
10=maximum pain.
|
0 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gordon Nuber, MD, Northwestern University
- Study Director: Antoun Nader, MD, Northwestern University
- Study Director: Lawrence Hsu, MD, Northwestern University
- Study Director: Mark Kendall, MD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
- Lundblad M, Kapral S, Marhofer P, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. doi: 10.1093/bja/ael241. Epub 2006 Sep 26.
- Arthornthurasook A, Gaew-Im K. Study of the infrapatellar nerve. Am J Sports Med. 1988 Jan-Feb;16(1):57-9. doi: 10.1177/036354658801600110.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
January 17, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (ESTIMATE)
January 19, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
May 12, 2014
Last Update Submitted That Met QC Criteria
April 14, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00026632
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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