- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409278
Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement
August 3, 2011 updated by: Saint Francis Care
The Evaluation of the Efficacy of Local Infiltration Analgesia and Infusion for Total Hip Arthroplasty
The purpose of this study is to examine three different ways to control pain after hip replacement:
- One time injection of ropivacaine before wound closure
- One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours
- Standard practice of patient controlled pump
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
105
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- total knee replacement
Exclusion Criteria:
- History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ropivacaine infiltration and infusion.
Ropivicaine infiltration followed by continuous ropivicaine infusion for 48 hours.
|
50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours.
|
Experimental: Ropivacaine and Saline
Ropivicaine infiltration followed by normal saline infusion.
|
50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour
|
Placebo Comparator: Saline infiltration and infusion.
Normal saline infiltration followed by saline infusion.
|
50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The pain medication requirement for 48 hours after surgery in three groups.
Time Frame: 48 hours after surgery
|
48 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain scores, incidence of nausea and vomiting and patient satisfaction in each group.
Time Frame: 48 hours after surgery
|
48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanjay Sinha, M.D., 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
August 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
June 1, 2011
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
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-07-002
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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