Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Infrapatellar Nerve Block for Post-operative Knee Arthroscopy Pain Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01279447
Recruitment Status : Completed
First Posted : January 19, 2011
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Larry Hsu, Northwestern University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Internal Derangement of Knee Drug: 0.25% Bupivacaine Drug: Normal Saline Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Infrapatellar Nerve Block for Post-operative Analgesia for Knee Arthroscopy
Study Start Date : January 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Sham Comparator: Placebo
A sham infrapatellar block performed under US guidance with normal saline
 Drug: Normal Saline
10cc, single dose, US guided injection
Other Name: Placebo
Experimental: Infrapatellar nerve block
An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
 Drug: 0.25% Bupivacaine
10cc, single dose, US guided injection
Other Name: Nerve block


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279447


Locations
Layout table for location information
United States, Illinois
Olson Surgical Pavilion
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Larry Hsu, Resident, Northwestern University
ClinicalTrials.gov Identifier: NCT01279447    
Other Study ID Numbers: STU00026632
First Posted: January 19, 2011    Key Record Dates
Results First Posted: May 12, 2014
Last Update Posted: May 12, 2014
Last Verified: January 2014
Keywords provided by Larry Hsu, Northwestern University:
infrapatellar nerve
saphenous nerve
knee arthroscopy
nerve block
Additional relevant MeSH terms:
Layout table for MeSH terms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents