Phase 2
N=240
Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset CRPS After TKA
CRPS
Bottom Line
View on ClinicalTrials.gov: NCT00558753 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Epidural Medication Consumption Rate — 6.40; 5.77 mL/h — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epidural Medication Consumption Rate |
6.40; 5.77 | 0.003 sig |
| SECONDARY Neuropathic Pain (S-LANSS > 12) |
10; 0; 6; 0 | 0.0013 sig |
| SECONDARY Knee Range of Motion (Active Flexion) |
75.6; 77.8; 76.7; 81.0; 80.4; 84.2 | 0.0133 sig |
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.
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- Prior usage of gabapentin (or pregabalin) will not be an exclusionary criterion; however, patients will have been withdrawn from these medications for at least 7 days before surgery.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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Data sourced from ClinicalTrials.gov (NCT00558753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.