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

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ClinicalTrials.gov Identifier: NCT00621530
Recruitment Status : Terminated (Terminated due to discontinuation of Acular PF (investigational medication))
First Posted : February 22, 2008
Results First Posted : July 27, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief 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.


Condition or disease Intervention/treatment Phase
Hip Arthroplasty Drug: ketorolac tromethamine opthalmic solution Drug: placebo Phase 2

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 prostaglandin E2 (PGE2) analysis in each patient. We will also assess each patient at 48 hours after their surgery for hypersensitivity at their surgical site.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity After Total Hip Arthroplasty
Study Start Date : March 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Ketorolac
ketorolac 2 mg ketorolac tromethamine opthalmic solution
Drug: ketorolac tromethamine opthalmic solution
ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery
Other Names:
  • Acular- Preservative Free (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




Primary Outcome Measures :
  1. Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery [ Time Frame: 48 hours ]
    Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery.


Secondary Outcome Measures :
  1. Present Pain Intensity [ Time Frame: 6 months ]
    Pain was assessed preoperatively, 2 days, and 2 and 6 months after surgery using a 0-10 (10 being worse) verbal Present Pain Intensity (PPI) scale

  2. McGill Pain Intensity [ Time Frame: 6 months ]
    Pain was assessed 2 days and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the intensity of their pain experience. This is termed the McGill Pain Intensity Score and is scored from 0 to 33 with 33 being the highest pain intensity.

  3. McGill Affective Pain [ Time Frame: 6 months ]
    Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the emotional component of their pain experience. This is termed the McGill Pain Affective Score and is scored from 0 to 12 with 12 being the highest pain emotional impact.

  4. Neuropathic Pain Symptom Inventory [ Time Frame: 6 months ]
    Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire to assess the degree of neuropathic characteristics of pain. This is termed the Neuropathic Pain Symptom Inventory which is scored 0-100 with 100 being the worst possible pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Wake Forest University
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: James C. Eisenach, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences ( Wake Forest University ):
Informed Consent Form  [PDF] May 1, 2009


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00621530     History of Changes
Other Study ID Numbers: IRB00004736
5R37GM048085 ( U.S. NIH Grant/Contract )
First Posted: February 22, 2008    Key Record Dates
Results First Posted: July 27, 2017
Last Update Posted: November 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wake Forest University Health Sciences ( 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
Ketorolac Tromethamine
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action