NCT00762099

Brief Summary

Pain prior to surgery is of particular concern in patients undergoing total hip arthroplasty (THA) since it is the most important predictor of pain and poor function 2-3 years after surgery. Previous studies have investigated various treatments for managing pain during and after surgery. However, no study has investigated the short and long term effects of pregabalin in terms of functional rehabilitation, pain outcome and anxiety following total hip arthroplasty. Therefore, the aim of the present study is determine if the following: (1) if perioperative pregabalin administration positively influence early rehabilitation and recovery of physical function and to determine if these effects maintained at 6 weeks and 3 months post surgery. (2) To determine if perioperative pregabalin administration reduce postoperative movement evoked pain associated with rehabilitation and if these effects also maintained at 6 weeks and 3 months post surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for phase_4 anxiety

Timeline
Completed

Started May 2009

Typical duration for phase_4 anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 8, 2011

Status Verified

April 1, 2011

Enrollment Period

2.6 years

First QC Date

September 29, 2008

Last Update Submit

April 7, 2011

Conditions

Anxiety

Keywords

Arthroplasty, HipHip replacementPain ManagementFunctional RehabilitationAnxietyPerioperativePregabalinArthroplasty

Outcome Measures

Primary Outcomes (1)

  • Physical function 6 weeks and 3-months post-total hip arthroplasty

    Up to 3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Pregabalin Group

Drug: Pregabalin

2

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

Interventions

PregabalinDRUG

Pre-operative dose 150 mg Post-operative dose 75 mg BID

Also known as: Lyrica
1
PlaceboDRUG

Placebo/sugar tabs will look identical to active drug.

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent, American Society of Anesthesiologists physical status I-III, VAS \> 5, age18-75 years, male or female, scheduled for THA.

You may not qualify if:

  • Patients will not be enrolled in this study for the following reasons:
  • Patients not providing informed consent.
  • Known allergy to any of the medications being used.
  • History of drug or alcohol abuse.
  • Patients with chronic pain on slow-release preparations of opioid.
  • Patients with Rheumatoid Arthritis.
  • Patients with psychiatric disorders.
  • Patients unable or unwilling to use Patient Controlled Analgesia. (PCA)
  • Diabetic patients or those with impaired renal function (Creatinine \>106).
  • Obese patients (i.e. BMI \> 40).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holland Orthopaedic and Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersAgnosia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Mental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Colin McCartney, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin McCartney, MD

CONTACT

416 480 6100colin.mccartney@sunnybrook.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2008

First Posted

September 30, 2008

Study Start

May 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 8, 2011

Record last verified: 2011-04

Locations

CA(1)