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AnxietyPhase 4RCTNCT00762099

Perioperative Pregabalin Use, Rehabilitation, Pain Outcomes and Anxiety Following Hip Surgery

A Phase 4 study testing Pregabalin in people with Anxiety, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Anxiety
What is being tested?
Pregabalin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
184 participants
Where
1 siteCanada
Study dates
May 2009to Dec 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Holland Orthopaedic and Arthritic Centre

    Toronto, Ontario, M4Y 1H1

    Hance Clarke, MD, 416-340-4800 ext. 6649, hance.clarke@utoronto.ca

    Colin McCartney, MD

    Recruiting

Other trials in Canada

About this study

Official title: The Short and Long Term Effects of Perioperative Pregabalin Use on Functional Rehabilitation, Pain Outcomes and Anxiety Following Total Hip Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial.

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.

Read the detailed description

INTRODUCTION. Participants are being asked to consider taking part in this research study if they are scheduled for total hip surgery. In this study we will compare the effect of a pain medication known as Pregabalin compared to placebo on rehabilitation and recovery of physical function and pain associated with rehabilitation. We will monitor patient progress in hospital and follow-up participants at 6 weeks and 3 months post surgery.

At the Holland Orthopedic and Arthritic Centre we use different methods to control postoperative pain. Postoperative pain relief is usually controlled with morphine using a pump that participants can control themselves, sometimes called "PCA" (Patient Controlled Analgesia). Participants also receive a combination of tablets like an anti-inflammatory (Celecoxib), and opioids (strong pain killers), to get the best pain relief possible with the fewest side effects. Anti-Inflammatories are a type of pain medicine that reduces swelling (inflammation). We would like to see compare the recovery profile of participants who receive in their pain management plan, the addition of Pregabalin with those who receive placebo.

WHY IS THIS STUDY BEING DONE? Pregabalin has recently been shown to reduce the amount of morphine participants use after surgery and enhance rehabilitation in some orthopedic participants. This study will examine whether Pregabalin added to a patient's pain management plan will help them rehabilitate more effectively and with less pain.

Part of this research will involve the collection of information from study participants that describes any pain or discomfort that they experience before and after surgery. After surgery, participants will be asked about how much pain they have by the nursing staff. In order to address these issues, they are asked to provide the following information at various intervals during their hospital stay:

  1. Pain intensity - using a Numeric Rating Scale (NRS) where 0=no pain and 10=Terrible Pain will be recorded three times daily during your hospital stay. Participants will also be asked to rate their pain after several rehabilitation measures on Postoperative days 1 to 4.
  2. Participants will also be asked if they are feeling nauseated, feel like vomiting, or feel drowsy.

After Total Hip Arthroplasty, it is important that all patients receive a standardized rehabilitation protocol. At the Holland Orthopedic and Arthritic Centre, the Primary Hip Replacement Care Pathway is accompanied by a standardized rehabilitation treatment protocol. While patients are in hospital, they will meet a physiotherapist who will put them through a series of hip exercises. The physiotherapist will record how much movement they can perform with their hip every day that they are in hospital.

On postoperative day 2 and day 4 study participants will, in addition to their daily hip exercises, be asked to perform a walking test to the best of ability. Participants will be timed, the physiotherapist will ask the participant to stand from a chair and walk 3 meters at a comfortable safe pace. Participants will then turn and walk back to the chair, and then sit down. In order that participants are familiar with that test we will perform that exercise before their operation so that we can obtain a baseline score. At the completion of the walking test, participants will also be asked to provide a final pain assessment of how painful the walking test was. On postoperative day 4, and at 6 weeks and at 3 months participants will be asked to perform some other rehabilitation measures. One will be a timed six minute walk test (only at 6 weeks and 3 months), that means we will measure how far they can walk in 6 minutes. The other measure will be one requiring participants to walk up stairs, they will have a good understanding of the above tests because they will have performed these tests prior to surgery.

Conditions
Anxiety
Being tested
Pregabalin, Placebo
Keywords
Arthroplasty, Hip, Hip replacement, Pain Management, Functional Rehabilitation, Anxiety, Perioperative, Pregabalin, Arthroplasty
Medical subject headings
Anxiety Disorders, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PregabalinDrug

    Also called Lyrica

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

  • PlaceboDrug

    Placebo/sugar tabs will look identical to active drug.

Study groups in NCT00762099
Study groupRoleWhat they receive
1Active comparatorPregabalin Group
Receives: Drug: Pregabalin
2Placebo comparatorPlacebo group
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2008 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00762099
Sponsor's protocol ID
2008-PFE-01
Acronym
RCT
Status last verified
Apr 2011
First submitted
29 Sep 2008
Last updated
8 Apr 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pregabalin in people with Anxiety, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Colin McCartney, MD (416 480 6100 ext. 1709, colin.mccartney@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical function 6 weeks and 3-months post-total hip arthroplasty (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2011.

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