Status:

TERMINATED

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

Lead Sponsor:

Wake Forest University

Collaborating Sponsors:

National Institute of General Medical Sciences (NIGMS)

Conditions:

Hip Arthroplasty

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 decrea...

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 ketor...

Eligibility Criteria

Inclusion

  • American Society of Anesthesiologists (ASA) physical status I, II, III
  • \> Age 18
  • Primary unilateral total hip arthroplasty under spinal anesthesia

Exclusion

  • 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

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2013

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT00621530

Start Date

March 1 2008

End Date

June 1 2013

Last Update

September 11 2018

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

2

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44120