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Sponsors and Collaborators: |
Wake Forest University National Institute of General Medical Sciences (NIGMS) |
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Information provided by: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00621530 |
Chronic pain in patients following total hip replacement seems to be a significant problem. Previous research has shown that more effective pain management in the early postoperative period may decrease the incidence of the development of chronic pain states.
This study will evaluate whether ketorolac (a non steroidal anti-inflammatory drug) given into the spinal fluid before surgery will reduce the area of sensitivity (or pain to light touch) following surgery. Patients will be monitored during their postoperative hospital stay and then contacted by telephone at 8 weeks and 6 months after surgery and questioned about any pain they are having at their surgical site. Patients that are still experiencing pain at 6 months will be asked to return to the medical center for the study staff to assess their pain or sensitivity at the surgical site.
Condition | Intervention | Phase |
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Hip Arthroplasty |
Drug: ketorolac tromethamine opthalmic solution Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity After Total Hip Arthroplasty |
Estimated Enrollment: | 100 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
ketorolac 2 mg
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Drug: ketorolac tromethamine opthalmic solution
ketorolac 2 mg or placebo will be added to the patient's routine spinal anesthetic for surgery
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2: Placebo Comparator
placebo will be added to the patient's routine spinal anesthetic for surgery
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Drug: placebo
ketorolac 2 mg or placebo will be added to the patient's routine spinal anesthetic for surgery
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Surgery results in hypersensitivity to mechanical stimuli surrounding the wound and in a subset of patients, also results in chronic pain. The purpose of the study is to test whether intrathecal ketorolac, by selectively and effectively blocking cyclooxygenase in the spinal cord, will reduce hypersensitivity surrounding the surgical wound in patients with high risk for developing chronic pain after surgery. We have chosen to study patients having total hip arthroplasty (THA) because chronic pain seems to be a significant problem after surgery. We will sample cerebrospinal fluid (CSF) prior to injection of the study medication for subsequent PGE2 analysis in each patient. We will also assess each patient at 48 hours after their surgery for hypersensitivity at their surgical site.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Regina Curry, RN, CCRC | 336-716-4294 | recurry@wfubmc.edu |
United States, North Carolina | |
Wake Forest University Baptist Medical Center | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Regina Curry, RN, CCRC 336-716-4294 recurry@wfubmc.edu | |
Principal Investigator: James C. Eisenach, MD | |
Sub-Investigator: James C. Crews, MD | |
Sub-Investigator: J.C. Gerancher, MD | |
Sub-Investigator: Pamela C. Nagle, MD |
Principal Investigator: | James C. Eisenach, MD | Wake Forest University |
Responsible Party: | Wake Forest University Health Sciences ( James C. Eisenach, M.D. ) |
Study ID Numbers: | IRB00004736, GM48085 |
Study First Received: | February 11, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00621530 |
Health Authority: | United States: Food and Drug Administration |
Total hip arthroplasty Total hip replacement Pain, postoperative Ketorolac Patients undergoing unilateral total hip arthroplasty |
Hypersensitivity Ketorolac Pain Ketorolac Tromethamine Pain, Postoperative |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |