Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset CRPS After TKA (PregTKA)
A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset Complex Regional Pain Syndrome After Total Knee Arthroplasty
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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- Prior usage of gabapentin (or pregabalin) will not be an exclusionary criterion; however, patients will have been withdrawn from these medications for at least 7 days before surgery.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).
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: 1 Placebo
Half of the patients will receive PO placebo for 14 days
|
Placebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days.
|
|
EXPERIMENTAL: 2 Pregabalin
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Epidural Medication Consumption Rate
Time Frame: 36 h
|
Epidural medication consumption was recorded for each 4-h interval from the completion of surgery to the time that the epidural was discontinued (same as the time to achieve hospital discharge criteria).
Because the discontinuation time varied from patient to patient (as they achieved physical therapy criteria), the average hourly consumption (total analgesic used divided by the total infusion time) was used as the measure of epidural drug use.
|
36 h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuropathic Pain (S-LANSS > 12)
Time Frame: 3 and 6 months post-surgery
|
Patients will be evaluated in blinded fashion for lower extremity Complex Regional Pain Syndrome(CRPS) at pre-op, 1, 3, and 6 months postsurgery based initially on telephone interviews.
An S-LANSS score of 12 or more was an indication of chronic neuropathic pain.
Patients with an Self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS) score of 12 or more at 6 mo came to the physician's office for a standardized physical examination, which included the S-LANSS examination items (allodynia and hyperalgesia) directly assessed by the physician, plus a pinprick evaluation.
|
3 and 6 months post-surgery
|
|
Knee Range of Motion (Active Flexion)
Time Frame: 1-30 days
|
1-30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- ABuv102007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.