- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01843153
Continuous Versus Intermittent Sciatic Block for Total Knee Arthroplasty
March 30, 2015 updated by: Kreiskrankenhaus Dormagen
Continuous Versus Intermittent Sciatic Block Combined With a Continuous Femoral Block for Patients Undergoing Total Knee Arthroplasty: a Prospective, Randomized Trial.
The role of a sciatic block in addition to a femoral block remains controversial.
The study addresses this topic by comparing a continuous block versus an injection on demand.
Study Overview
Study Type
Interventional
Enrollment (Actual)
140
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
-
-
-
Dormagen, Germany, D-51375
- KKH Dormagen
-
-
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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for total knee arthroplasty
Exclusion Criteria:
- failure to establish femoral and sciatic block
- insufficient analgesic effect of the block
- patient declines to participate
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: intermittent
injection of ropivacaine on demand
|
|
|
Other: continuous
continuous ropivacaine infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pain score (VRS)
Time Frame: 4 days
|
4 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
frequency of injections into the sciatic catheter
Time Frame: 4 days
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
April 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
April 25, 2013
First Submitted That Met QC Criteria
April 29, 2013
First Posted (Estimate)
April 30, 2013
Study Record Updates
Last Update Posted (Estimate)
March 31, 2015
Last Update Submitted That Met QC Criteria
March 30, 2015
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- sciatic block
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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