Effects of Pregabalin on Pain After Total Knee Arthroplasty

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Total Knee Arthroplasty

Treatments: Drug: Placebo; Drug: Pregabalin 150mg; Drug: Pregabalin 50mg; Drug: Pregabalin 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01333956

11043

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Patients will receive 0mg of pregabalin

Treatment:

Drug: Placebo

50mg Arm

Experimental group

Description:

Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.

Treatment:

Drug: Pregabalin 50mg

100mg Arm

Experimental group

Description:

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.

Treatment:

Drug: Pregabalin 100mg

150mg Arm

Experimental group

Description:

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.

Treatment:

Drug: Pregabalin 150mg