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

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James C. Eisenach, M.D.; Wake Forest University
• Collaborator: National Institute of General Medical Sciences (NIGMS)
• Treatments: Anesthetics; Ketorolac; Ketorolac Tromethamine

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