Effects of Pregabalin on Pain After Total Knee Arthroplasty

Primary Total Knee Arthroplasty Clinical Trial

Official title:

Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333956
• Other study ID #: 11043
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 8, 2011
• Last updated: March 25, 2015
• Start date: May 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2015
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Total knee arthroplasty can cause severe postoperative pain, and patients typically receive oral opioid analgesics for over 2 weeks. Side effects of pain management may impair participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems that pregabalin is very helpful to patients after total knee arthroplasty. However, pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses may not be effective, but use of high doses may increase the incidence and severity of side effects.The purpose of this study is to determine which dosage of pregabalin is the most effective at reducing pain after knee surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon

• Age 18 to 80 years old

• Planned use of regional anesthesia

• Ability to follow study protocol

• English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)

• Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

• Patients younger than 18 years old and older than 80

• Patients intending to receive general anesthesia

• Allergy or intolerance to one of the study medications

• Patients with an ASA of IV

• Patients with hepatic (liver) failure

• Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance < 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr < 30 mL/min, CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)])

• Patients with difficult to manage diabetes mellitus, including insulin-dependence

• Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

• Chronic opioid use (taking opioids for longer than 3 months)

• Patients with major prior ipsilateral open knee surgery.

• Chronic neurontin/lyrica use

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Total Knee Arthroplasty

Intervention

Drug:
• Pregabalin 50mg
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
• Pregabalin 100mg
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
• Pregabalin 150mg
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
• Placebo
Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	How much pregabalin is needed to reduce pain (occurring at rest and with activity) after total knee arthroplasty (TKA) at 2 weeks after surgery?	2 weeks postoperatively	No
Secondary	Opioid-Related Symptom Distress Score	Opioid-Related Symptom Distress score (postoperative day [POD] 1, 2 weeks)	2 weeks postoperatively	No
Secondary	Self-assessed Sedation and Confusion	Self-assessed sedation and confusion (POD1, POD3). Confusion Assessment Method (CAM score) (pre-operative and on POD1)	3 days postoperatively	No
Secondary	Numeric Rating Scale (NRS) and Neuropathic Pain	NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)	3 months	No
Secondary	Opioid Usage	Opioid Usage (POD1, POD 3, 2 weeks, 3 months)	3 months	No
Secondary	Orthopedic Outcomes	Orthopedic outcomes (6 weeks and 3 months, at routine postoperative visits) as determined via the orthopedic knee society score and knee society score function tests. Data gathered will include range of motion (degrees), flexion contracture (degrees), contraction (degrees), alignment (degrees varus or valgus), pain while walking, number of blocks walked, use of walking aids, and ability to climb stairs.	3 months	No
Secondary	Satisfaction	Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)	2 weeks	No