Perioperative Pregabalin Use, Rehabilitation, Pain Outcomes and Anxiety Following Hip Surgery (RCT)
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|ClinicalTrials.gov Identifier: NCT00762099|
Recruitment Status : Unknown
Verified April 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was: Recruiting
First Posted : September 30, 2008
Last Update Posted : April 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anxiety||Drug: Pregabalin Drug: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
Active Comparator: 1
Pre-operative dose 150 mg Post-operative dose 75 mg BID
Other Name: Lyrica
Placebo Comparator: 2
Placebo/sugar tabs will look identical to active drug.
- Physical function 6 weeks and 3-months post-total hip arthroplasty [ Time Frame: Up to 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762099
|Contact: Colin McCartney, MD||416 480 6100 ext email@example.com|
|Holland Orthopaedic and Arthritic Centre||Recruiting|
|Toronto, Ontario, Canada, M4Y 1H1|
|Contact: Hance Clarke, MD 416-340-4800 ext 6649 firstname.lastname@example.org|
|Principal Investigator: Colin McCartney, MD|
|Principal Investigator:||Colin McCartney, MD||Sunnybrook Health Sciences Centre|