- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415193
Tibial Nerve Versus Sciatic Nerve Block
March 17, 2015 updated by: Saint Francis Care
Selective Tibial Nerve Block vs Popliteal Sciatic Nerve Block in Patients Having Total Knee Arthroplasty
The purpose of this study is to analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve.
To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
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
-
-
Connecticut
-
Hartford, Connecticut, United States, 06105
- Saint Francis Hospital and Medical Center
-
-
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 to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- total knee replacement
Exclusion Criteria:
- History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Selective Tibial Nerve Block
|
Use of selective pain block.
|
Active Comparator: Control: Sciatic Nerve Block
|
Use of Sciatic Nerve Block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop.
Time Frame: Upon emergence from general anesthesia and up to 48 hours in the recovery room.
|
Measure frequency of foot drop in two groups and compare results.
|
Upon emergence from general anesthesia and up to 48 hours in the recovery room.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess if levels of pain and analgesic requirements are similar between the two groups.
Time Frame: 24 hours after total knee replacement surgery.
|
Administer pain scale and monitor use of analgesics to compare levels two groups.
|
24 hours after total knee replacement surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanjay Sinha, MD, Saint Francis Memorial Hospital
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
March 1, 2009
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 1, 2011
First Submitted That Met QC Criteria
August 10, 2011
First Posted (Estimate)
August 11, 2011
Study Record Updates
Last Update Posted (Estimate)
March 18, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
August 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 09-02-002
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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