Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01279447
Other study ID # STU00026632
Secondary ID
Status Completed
Phase Phase 4
First received January 17, 2011
Last updated April 14, 2014
Start date January 2011
Est. completion date August 2013

Study information

Verified date January 2014
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
0.25% Bupivacaine
10cc, single dose, US guided injection
Normal Saline
10cc, single dose, US guided injection

Locations

Country Name City State
United States Olson Surgical Pavilion Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gümüs 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. — View Citation

Arthornthurasook A, Gaew-Im K. Study of the infrapatellar nerve. Am J Sports Med. 1988 Jan-Feb;16(1):57-9. — View Citation

Lundblad M, Kapral S, Marhofer P, Lönnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. Epub 2006 Sep 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Post op Pain Score immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain. 0 hours No