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

NCT00558753 | Completed Phase 2 Results

• 1 other identifier: ABuv102007
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CRPS

Outcome Measures

Primary Outcomes (1)

• Epidural Medication Consumption Rate

  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 Outcomes (2)

• Neuropathic Pain (S-LANSS > 12)

  3 and 6 months post-surgery

• Knee Range of Motion (Active Flexion)

  1-30 days

Study Arms (2)

1 Placebo

PLACEBO COMPARATOR

Half of the patients will receive PO placebo for 14 days

Drug: Placebo

2 Pregabalin

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

Interventions

pregabalin DRUG

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.

Also known as: Lyrica

2 Pregabalin

Placebo DRUG

Placebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days.

1 Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Younger than 21 years or older than 80 years.
• American Society of Anesthesiologists physical status IV.
• 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).

Sponsors & Collaborators

• Rush University Medical Center: lead
• Pfizer: collaborator

Related Publications (1)

• Buvanendran A, Kroin JS, Della Valle CJ, Kari M, Moric M, Tuman KJ. Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):199-207. doi: 10.1213/ANE.0b013e3181c4273a. Epub 2009 Nov 12.

  PMID: 19910619 RESULT

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Asokumar Buvanendran, M.D.
• Organization: Rush University Medical Center

asokumar@aol.com

(312) 942-3685

Study Officials

• Asokumar Buvanendran, M.D.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: April 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 26, 2016
• Results First Posted: August 27, 2012

Record last verified: 2016-04