- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409460
Obturator Nerve Block With Femoral and Sciatic Block
August 3, 2011 updated by: Saint Francis Care
Is an Obturator Nerve Block Required for Every Patient Having Total Knee Arthroplasty With Femoral and Sciatic Nerve Block?
The purpose of this study is to evaluate how many patients require the addition of the obturator nerve block in the recovery room after the total knee surgery.
Also to study the efficacy of blocking the obturator nerve in controlling their knee pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
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
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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:
- Hisory of neurologica disease, diabetes, pregnancy, neuropathy
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: True Obturator Nerve Block
|
Use of selective pain block.
|
|
Sham Comparator: Sham Block
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Five minutes after the sham block pain was assessed in these patients.
If pain score was 5 or greater a true obturator nerve block was performed on these patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To assess the use of obturator Nerve block for patients undergoing total knee arthroplasty
Time Frame: 15 minutes in recovery room post operatively
|
The need for rescue obturator nerve block in total knee arthoplasty patients who have sucessful femoral nerve block and sciatic nerve block in place.
|
15 minutes in recovery room post operatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain medication use intra-operatively and in the recovery room after surgery. Pain scores in recovery room.
Time Frame: During surgery and until discharge from recovery room.
|
During surgery and until discharge from recovery room.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
October 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
August 2, 2011
First Submitted That Met QC Criteria
August 3, 2011
First Posted (Estimate)
August 4, 2011
Study Record Updates
Last Update Posted (Estimate)
August 4, 2011
Last Update Submitted That Met QC Criteria
August 3, 2011
Last Verified
October 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 08-10-003
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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