Clinical trial NCT00621530: Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement
Official title: Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hip Arthroplasty
Keywords: Total hip arthroplasty
Total hip replacement
Pain, postoperative
Ketorolac
Patients undergoing unilateral total hip arthroplasty
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2008-02-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery
timeFrame: 48 hours
Secondary outcomes:
measure: Present Pain Intensity
timeFrame: 6 months
measure: McGill Pain Intensity
timeFrame: 6 months
measure: McGill Affective Pain
timeFrame: 6 months
measure: Neuropathic Pain Symptom Inventory
timeFrame: 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Wake Forest University Health Sciences
name: James C. Eisenach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang L, Bauer M, Curry R, Larsson A, Sessler DI, Eisenach JC. Intrathecal ketorolac does not improve acute or chronic pain after hip arthroplasty: a randomized controlled trial. J Anesth. 2014 Oct;28(5):790-3. doi: 10.1007/s00540-014-1798-6. Epub 2014 Feb 18.