Effects of Pregabalin on Pain After Total Knee Arthroplasty

NCT01333956 | Completed Phase 1 Results

• 1 other identifier: 11043
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).

  2 weeks postoperatively

Secondary Outcomes (6)

• Opioid-Related Symptom Distress Score

  2 weeks postoperatively

• Self-assessed Sedation and Confusion

  1 day postoperatively

• Numeric Rating Scale (NRS)

  3 months

• Neuropathic Pain

  3 months

• Opioid Usage

  3 months

Study Arms (4)

Control

PLACEBO COMPARATOR

Patients will receive 0mg of pregabalin

Drug: Placebo

50mg Arm

EXPERIMENTAL

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.

Drug: Pregabalin 50mg

100mg Arm

EXPERIMENTAL

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.

Drug: Pregabalin 100mg

150mg Arm

EXPERIMENTAL

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.

Drug: Pregabalin 150mg

Interventions

Pregabalin 50mg DRUG

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.

Also known as: Lyrica

50mg Arm

Pregabalin 100mg DRUG

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.

Also known as: Lyrica

100mg Arm

Pregabalin 150mg DRUG

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.

Also known as: Lyrica

150mg Arm

Placebo DRUG

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.

Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

• YaDeau JT, Lin Y, Mayman DJ, Goytizolo EA, Alexiades MM, Padgett DE, Kahn RL, Jules-Elysee KM, Ranawat AS, Bhagat DD, Fields KG, Goon AK, Curren J, Westrich GH. Pregabalin and pain after total knee arthroplasty: a double-blind, randomized, placebo-controlled, multidose trial. Br J Anaesth. 2015 Aug;115(2):285-93. doi: 10.1093/bja/aev217.

  PMID: 26170351 DERIVED

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: Dr. Jacques YaDeau
• Organization: Hospital for Special Surgery

yadeauj@hss.edu

212-606-1206

Study Officials

• Jacques T YaDeau, M.D., Ph.D.

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 12, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 18, 2016
• Results First Posted: May 18, 2016

Record last verified: 2016-04

Locations

US (1)