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

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Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-Onset CRPS After TKA (PregTKA)

This study is ongoing, but not recruiting participants.

Study NCT00558753. Last updated on November 14, 2007. Information provided by Rush University Medical Center

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-Onset Complex Regional Pain Syndrome After Total Knee Arthroplasty

Brief Summary

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.

Detailed Description

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

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 ]
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 ]

Condition ^†

CRPS

Intervention ^†

Drug: pregabalin

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

300

Start Date ^†

April 2006

Completion Date

November 2007

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria:

Younger than 21 years or older than 80 years.
American Society of Anesthesiologists physical status IV.
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.
Patients with a history of neuropathic pain conditions.
Patients who are currently enrolled in another investigational study.
Pre-existing heart conditions
Patients on thiazolidinedione class of anti-diabetic medications (eg. rosiglitazone, pioglitazone).

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Gender

Both

Ages

21 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00558753

Organization ID

ABuv102007

Secondary IDs ^††

Study Sponsor ^†

Rush University Medical Center

Collaborators ^††

Pfizer

Investigators ^†

Principal Investigator:

Asokumar Buvanendran, M.D.

Rush University Medical Center

Information Provided By

Rush University Medical Center

Verification Date

November 2007

First Received Date ^†

November 14, 2007

Last Updated Date

November 14, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.