Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement
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Purpose
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 |
|---|---|---|
|
Hip Arthroplasty |
Drug: ketorolac tromethamine opthalmic solution Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity After Total Hip Arthroplasty |
- The primary outcome measure, area of hypersensitivity to mechanical stimuli surrounding the wound 48 hr after surgery, remains the same and is only a surrogate measure for developing chronic pain. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- A secondary purpose of this study is to determine the predictive value of 3 simple preoperative tests for severity of acute pain following surgery [ Time Frame: Study completion (6 months) ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: 1
ketorolac 2 mg
|
Drug: ketorolac tromethamine opthalmic solution
ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery
Other Names:
|
|
Placebo Comparator: 2
placebo will be added to the patient's routine spinal anesthetic for surgery
|
Drug: placebo
placebo will be added to the patient's routine spinal anesthetic for surgery
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA physical status I, II, III
- > Age 18
- Primary unilateral total hip arthroplasty under spinal anesthesia
Exclusion Criteria:
- Known allergy to study medication
- Weight > 300 pounds
- Obstructive sleep apnea
- Patients with severe renal (kidney) or hepatic (liver) disease, allergy to ketorolac, amino amide local anesthetic, or contraindications to spinal anesthesia
- Patients on dialysis for kidney failure or patients that are jaundice or have a diagnosis of liver failure
- Patients routinely taking narcotic pain medications for pain other than their primary hip pain
- Patients that are taking Lyrica (pregabalin) or Gabapentin (neurontin) for the treatment of seizures
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44120 | |
| Principal Investigator: | James C. Eisenach, MD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | James C. Eisenach, M.D., Professor, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00621530 History of Changes |
| Other Study ID Numbers: | IRB00004736, GM48085 |
| Study First Received: | February 11, 2008 |
| Last Updated: | February 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wake Forest University:
|
Total hip arthroplasty Total hip replacement Pain, postoperative Ketorolac Patients undergoing unilateral total hip arthroplasty |
Additional relevant MeSH terms:
|
Hypersensitivity Immune System Diseases Anesthetics Ketorolac Tromethamine Ketorolac Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013