Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement - Full Text View

Sponsors and Collaborators:	Wake Forest University National Institute of General Medical Sciences (NIGMS)
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00621530

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 II

MedlinePlus related topics: Allergy Surgery

Drug Information available for: Ketorolac Ketorolac tromethamine Tromethamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity After Total Hip Arthroplasty

Further study details as provided by Wake Forest University:

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, 8 weeks and 6 months ] [ 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 ]

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator ketorolac 2 mg	Drug: ketorolac tromethamine opthalmic solution ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery
2: Placebo Comparator 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

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

Contacts

Contact: Regina Curry, RN, CCRC

336-716-4294

recurry@wfubmc.edu

Locations

United States, North Carolina
Wake Forest University Baptist Medical Center	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Regina Curry, RN, CCRC 336-716-4294 recurry@wfubmc.edu
Principal Investigator: James C. Eisenach, MD
Sub-Investigator: James C. Crews, MD
Sub-Investigator: J.C. Gerancher, MD
Sub-Investigator: Pamela C. Nagle, MD

Sponsors and Collaborators

Wake Forest University

National Institute of General Medical Sciences (NIGMS)

Investigators

Principal Investigator:

James C. Eisenach, MD

Wake Forest University

More Information

No publications provided

Responsible Party:	Wake Forest University Health Sciences ( James C. Eisenach, M.D. )
Study ID Numbers:	IRB00004736, GM48085
Study First Received:	February 11, 2008
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00621530 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wake Forest University:

Total hip arthroplasty
Total hip replacement
Pain, postoperative
Ketorolac
Patients undergoing unilateral total hip arthroplasty

Study placed in the following topic categories:

Anti-Inflammatory Agents
Ketorolac
Cyclooxygenase Inhibitors
Anesthetics
Pain
Hypersensitivity
Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Ketorolac Tromethamine
Antirheumatic Agents
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Cyclooxygenase Inhibitors
Ketorolac
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Hypersensitivity

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Ketorolac Tromethamine
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009