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Sponsors and Collaborators: |
Duke University Pfizer |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00620828 |
The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis |
Other: Placebo saline injection Drug: Ropivicaine 0.5% |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Trial |
Estimated Enrollment: | 90 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Block Negative: Placebo Comparator
Subjects receive intra-op saline injection per protocol
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Other: Placebo saline injection
20 cc of sterile, injectable saline
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Block Positive: Experimental
Subjects receive intra-op Ropivicaine 0.5% injection per protocol
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Drug: Ropivicaine 0.5%
Ropivicaine
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael P Bolognesi, M.D. | (919) 668-4732 | michael.bolognesi@duke.edu |
Contact: David Attarian, M.D. | (919) 668-4732 | david.attarian@duke.edu |
United States, North Carolina | |
Duke University Adult Reconstructive Surgery | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Michael P Bolognesi, M.D. 919-668-4732 michael.bolognesi@duke.edu |
Principal Investigator: | Michael P Bolognesi, M.D. | Duke University |
Responsible Party: | Duke University Medical Center ( Michael P. Bolognesi/Director of Adult Reconstructive Surgery ) |
Study ID Numbers: | 00000233, SPS# 139715 |
Study First Received: | February 12, 2008 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00620828 History of Changes |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Postoperative Complications Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases Pain, Postoperative |
Signs and Symptoms Pathologic Processes Postoperative Complications Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Pain Rheumatic Diseases Pain, Postoperative |