Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement

This study has been terminated.
(Terminated due to discontinuation of Acular PF (investigational medication))
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James C. Eisenach, M.D., Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00621530
First received: February 11, 2008
Last updated: May 28, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: March 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketorolac
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:
  • Acular-PF
  • Ketorolac
Placebo Comparator: Placebo
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621530

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
Sponsors and Collaborators
James C. Eisenach, M.D.
Investigators
Principal Investigator: James C. Eisenach, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: James C. Eisenach, M.D., Professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00621530     History of Changes
Other Study ID Numbers: IRB00004736, GM48085
Study First Received: February 11, 2008
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wake Forest School of Medicine:
Total hip arthroplasty
Total hip replacement
Pain, postoperative
Ketorolac
Patients undergoing unilateral total hip arthroplasty

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Ketorolac
Ketorolac Tromethamine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014