Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement
Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hip Arthroplasty
Intervention: ketorolac tromethamine opthalmic solution (Drug); placebo (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: James C. Eisenach, M.D. Official(s) and/or principal investigator(s): James C. Eisenach, MD, Principal Investigator, Affiliation: Wake Forest School of Medicine
Summary
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.
Clinical Details
Official title: Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity After Total Hip Arthroplasty
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: A secondary purpose of this study is to determine the predictive value of 3 simple preoperative tests for severity of acute pain following 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States
The Cleveland Clinic Foundation, Cleveland, Ohio 44120, United States
Additional Information
Starting date: March 2008
Last updated: May 28, 2014
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