Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-Onset CRPS After TKA - Full Text View

Sponsors and Collaborators:	Rush University Medical Center Pfizer
Information provided by:	Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT00558753

Purpose

The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA) is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor, including sweating; and movement disorders and dystrophy, including decreased range of motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.

Condition	Intervention	Phase
CRPS	Drug: pregabalin	Phase II

MedlinePlus related topics: Complex Regional Pain Syndrome Knee Replacement

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-Onset Complex Regional Pain Syndrome After Total Knee Arthroplasty

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:

During the immediate postoperative phase, the total epidural medication consumption will be recorded for each 4 hour interval over this study period of 36 hours. [ Time Frame: 36 h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Patients will be evaluated in blinded fashion for lower extremity CRPS at pre-op, 1, 3, and 6 months postsurgery based initially on telephone interviews. [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: Yes ]
The degree of active and passive knee flexion and the number of days required until obtaining 90º of active knee flexion will be recorded by the physical therapist twice daily until discharged from the hospital. [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	April 2006
Study Completion Date:	June 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Half of the patients will receive PO placebo for 14 days	Drug: pregabalin twice/day; 14 days
2: Experimental PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.	Drug: pregabalin twice/day; 14 days

Detailed Description:

The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA) is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor, including sweating; and movement disorders and dystrophy, including decreased range of motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin. Gabapentin and the related more potent compound pregabalin have been shown to reduce postoperative pain in animal models. Pregabalin also reduces neuropathic pain in rats. In patients, gabapentin has been administered before surgery to treat postoperative pain. In addition, pregabalin has been given postoperatively to reduce dental pain after molar extraction. Gabapentin has been used for many years in patients with neuropathic pain, including reflex sympathetic dystrophy. More recently, pregabalin has also been shown to be efficacious in the treatment of neuropathic pain. However, no clinical study has investigated whether perioperative administration of gabapentin or pregabalin can reduce persistent long-term pain syndromes e.g. CRPS.Subjects between the ages of 21 and 80 will be recruited after obtaining an Informed Consent.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of osteoarthritis
Subjects who can understand and communicate in English.

Exclusion Criteria:

1.Younger than 21 years or older than 80 years. 2. American Society of Anesthesiologists physical status IV. 3. Prior usage of gabapentin (or pregabalin) will not be an exclusionary criterion; however, patients will have been withdrawn from these medications for at least 7 days before surgery. 4. Patients with a history of neuropathic pain conditions. 5. Patients who are currently enrolled in another investigational study. 6. Pre-existing heart conditions 7. Patients on thiazolidinedione class of anti-diabetic medications (eg. rosiglitazone, pioglitazone).

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558753

Sponsors and Collaborators

Rush University Medical Center

Pfizer

Investigators

Principal Investigator:

Asokumar Buvanendran, M.D.

Rush University Medical Center

More Information

No publications provided

Responsible Party:	Rush University Medical Center ( Asokumar Buvanendran, MD )
Study ID Numbers:	ABuv102007
Study First Received:	November 14, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00558753 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autonomic Nervous System Diseases
Neuromuscular Diseases
Complex Regional Pain Syndromes
Peripheral Nervous System Diseases
Pregabalin

Pain
Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:

Nervous System Diseases
Physiological Effects of Drugs
Pregabalin
Pharmacologic Actions
Autonomic Nervous System Diseases
Complex Regional Pain Syndromes
Neuromuscular Diseases

Sensory System Agents
Peripheral Nervous System Diseases
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009