Primary Total Knee ArthroplastyPhase 1/2NCT01333956
Effects of Pregabalin on Pain After Total Knee Arthroplasty
A Phase 1/2 study testing Pregabalin 50mg, Pregabalin 100mg and Pregabalin 150mg in people with Primary Total Knee Arthroplasty, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Total Knee Arthroplasty
- What is being tested?
- Pregabalin 50mg, Pregabalin 100mg and Pregabalin 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)])
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial
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
- Being tested
- Pregabalin 50mg, Pregabalin 100mg, Pregabalin 150mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 50mgDrug
Also called Lyrica
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.
Pregabalin 100mgDrug
Also called Lyrica
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.
Pregabalin 150mgDrug
Also called Lyrica
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients will receive 0mg of pregabalin Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Pregabalin 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).
Measured: 2 weeks postoperatively
Secondary outcomes (6)
Opioid-Related Symptom Distress Score
Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high).
Measured: 2 weeks postoperatively
Self-assessed Sedation and Confusion
Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1)
Measured: 1 day postoperatively
Numeric Rating Scale (NRS)
NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)
Measured: 3 months
Neuropathic Pain
Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes.
Measured: 3 months
Opioid Usage
Opioid Usage (POD1, POD 3, 2 weeks, 3 months)
Measured: 3 months
Satisfaction
Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques T YaDeau, M.D., Ph.D., Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333956
- Sponsor's protocol ID
- 11043
- Status last verified
- Apr 2016
- First submitted
- 8 Apr 2011
- Last updated
- 18 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 26170351
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial
- ClinicalTrials.gov ID
- NCT01333956
- Acronym / sponsor ID
- 11043
- Conditions
- Primary Total Knee Arthroplasty
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Posted 18 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboPatients will receive 0mg of pregabalin |
| 50mg Arm | Experimental | Drug: Pregabalin 50mgPatients 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. |
| 100mg Arm | Experimental | Drug: Pregabalin 100mgPatients 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. |
| 150mg Arm | Experimental | Drug: Pregabalin 150mgPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Pregabalin 50mgAlso: LyricaPatients 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. | Drug | 50mg Arm |
| Pregabalin 100mgAlso: LyricaPatients 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 | 100mg Arm |
| Pregabalin 150mgAlso: LyricaPatients 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 | 150mg Arm |
| PlaceboPatients 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. | Drug | Control |
Primary outcome
Postoperative Pain
Time frame: 2 weeks postoperatively
Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).
6 secondary outcomes
Opioid-Related Symptom Distress Score
Time frame: 2 weeks postoperatively
Self-assessed Sedation and Confusion
Time frame: 1 day postoperatively
Numeric Rating Scale (NRS)
Time frame: 3 months
Neuropathic Pain
Time frame: 3 months
Opioid Usage
Time frame: 3 months
Satisfaction
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26170351YaDeau 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.
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Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
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Ultrasound Guided Combined Adductor Canal, Superior Genicular Nerves and Anterior Femoral Cutaneous Nerves Blocks in Comparison With Periarticular Local Anesthesia Infiltration in Primary Total Knee Arthroplasty
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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.
Jacques T YaDeau, M.D., Ph.D. principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pregabalin 50mg, Pregabalin 100mg and Pregabalin 150mg in people with Primary Total Knee Arthroplasty, run by Hospital for Special Surgery, New York at 1 site in United States.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 18 May 2016. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 2 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01333956, which also lists 1 linked publication.
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 18 May 2016.