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.
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
- 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
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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pregabalin Group Receives: Drug: Pregabalin |
| 2 | Placebo comparator | Placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted30 Sep 2008 (estimated)
- Study startMay 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Colin McCartney, MD, Principal investigator, Sunnybrook Health Sciences Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00762099
- Acronym / sponsor ID
- RCT / 2008-PFE-01
- Conditions
- Anxiety
- Keywords
- Arthroplasty, Hip, Hip replacement, Pain Management, Functional Rehabilitation, Anxiety, Perioperative, Pregabalin, Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PregabalinPregabalin Group |
| 2 | Placebo comparator | Drug: PlaceboPlacebo group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Provision of informed consent, American Society of Anesthesiologists physical status I-III, VAS > 5, age18-75 years, male or female, scheduled for THA.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: LyricaPre-operative dose 150 mg Post-operative dose 75 mg BID | Drug | 1 |
| PlaceboPlacebo/sugar tabs will look identical to active drug. | Drug | 2 |
Primary outcome
Physical function 6 weeks and 3-months post-total hip arthroplasty
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin McCartney, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
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.