CRPSPhase 2PregTKANCT00558753
Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset CRPS After TKA
A Phase 2 study testing pregabalin in people with CRPS, run by Rush University Medical Center.
Trial summary
The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- CRPS
- What is being tested?
- pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Jun 2010
- Phase
- Phase 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of osteoarthritis
- Subjects who can understand and communicate in English.
Who cannot join
- Younger than 21 years or older than 80 years.
- American Society of Anesthesiologists physical status IV.
- Prior usage of gabapentin (or pregabalin) will not be an exclusionary criterion; however, patients will have been withdrawn from these medications for at least 7 days before surgery.
- Patients with a history of neuropathic pain conditions.
- Patients who are currently enrolled in another investigational study.
- Pre-existing heart conditions
- Patients on thiazolidinedione class of anti-diabetic medications (eg. rosiglitazone, pioglitazone).
- -
About this study
Official title: A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset Complex Regional Pain Syndrome After Total Knee Arthroplasty
The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA) is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor, including sweating; and movement disorders and dystrophy, including decreased range of motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.
Read the detailed description
The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA) is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor, including sweating; and movement disorders and dystrophy, including decreased range of motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.
Gabapentin and the related more potent compound pregabalin have been shown to reduce postoperative pain in animal models. Pregabalin also reduces neuropathic pain in rats. In patients, gabapentin has been administered before surgery to treat postoperative pain. In addition, pregabalin has been given postoperatively to reduce dental pain after molar extraction. Gabapentin has been used for many years in patients with neuropathic pain, including reflex sympathetic dystrophy. More recently, pregabalin has also been shown to be efficacious in the treatment of neuropathic pain. However, no clinical study has investigated whether perioperative administration of gabapentin or pregabalin can reduce persistent long-term pain syndromes e.g. CRPS.Subjects between the ages of 21 and 80 will be recruited after obtaining an Informed Consent.
- Conditions
- CRPS
- Being tested
- pregabalin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalinDrug
Also called Lyrica
PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
PlaceboDrug
Placebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days.
| Study group | Role | What they receive |
|---|---|---|
| 1 Placebo | Placebo comparator | Half of the patients will receive PO placebo for 14 days Receives: Drug: Placebo |
| 2 Pregabalin | Experimental | PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped. Receives: Drug: pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural Medication Consumption Rate
Epidural medication consumption was recorded for each 4-h interval from the completion of surgery to the time that the epidural was discontinued (same as the time to achieve hospital discharge criteria). Because the discontinuation time varied from patient to patient (as they achieved physical therapy criteria), the average hourly consumption (total analgesic used divided by the total infusion time) was used as the measure of epidural drug use.
Measured: 36 h
Secondary outcomes (2)
Neuropathic Pain (S-LANSS > 12)
Patients will be evaluated in blinded fashion for lower extremity Complex Regional Pain Syndrome(CRPS) at pre-op, 1, 3, and 6 months postsurgery based initially on telephone interviews. An S-LANSS score of 12 or more was an indication of chronic neuropathic pain. Patients with an Self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS) score of 12 or more at 6 mo came to the physician's office for a standardized physical examination, which included the S-LANSS examination items (allodynia and hyperalgesia) directly assessed by the physician, plus a pinprick evaluation.
Measured: 3 and 6 months post-surgery
Knee Range of Motion (Active Flexion)
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startApr 2006
- Primary completionJun 2010
- Study completionJun 2010
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 CRPSStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Asokumar Buvanendran, Rush University Medical Center
- Investigators
- Asokumar Buvanendran, M.D., Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558753
- Sponsor's protocol ID
- ABuv102007
- Acronym
- PregTKA
- Status last verified
- Apr 2016
- First submitted
- 14 Nov 2007
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Buvanendran A, Kroin JS, Della Valle CJ, Kari M, Moric M, Tuman KJ. Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):199-207. doi: 10.1213/ANE.0b013e3181c4273a. Epub 2009 Nov 12.
PubMed 19910619
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset Complex Regional Pain Syndrome After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00558753
- Acronym / sponsor ID
- PregTKA / ABuv102007
- Conditions
- CRPS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Nov 2007 (estimated)
- Results
- Posted 27 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA) is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor, including sweating; and movement disorders and dystrophy, including decreased range of motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.
Detailed description
The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA) is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor, including sweating; and movement disorders and dystrophy, including decreased range of motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.
Gabapentin and the related more potent compound pregabalin have been shown to reduce postoperative pain in animal models. Pregabalin also reduces neuropathic pain in rats. In patients, gabapentin has been administered before surgery to treat postoperative pain. In addition, pregabalin has been given postoperatively to reduce dental pain after molar extraction. Gabapentin has been used for many years in patients with neuropathic pain, including reflex sympathetic dystrophy. More recently, pregabalin has also been shown to be efficacious in the treatment of neuropathic pain. However, no clinical study has investigated whether perioperative administration of gabapentin or pregabalin can reduce persistent long-term pain syndromes e.g. CRPS.Subjects between the ages of 21 and 80 will be recruited after obtaining an Informed Consent.
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 Placebo | Placebo comparator | Drug: PlaceboHalf of the patients will receive PO placebo for 14 days |
| 2 Pregabalin | Experimental | Drug: pregabalinPO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of osteoarthritis
- Subjects who can understand and communicate in English.
Key exclusion criteria (8 listed)
- Younger than 21 years or older than 80 years.
- American Society of Anesthesiologists physical status IV.
- Prior usage of gabapentin (or pregabalin) will not be an exclusionary criterion; however, patients will have been withdrawn from these medications for at least 7 days before surgery.
- Patients with a history of neuropathic pain conditions.
- Patients who are currently enrolled in another investigational study.
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: LyricaPO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped. | Drug | 2 Pregabalin |
| PlaceboPlacebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days. | Drug | 1 Placebo |
Primary outcome
Epidural Medication Consumption Rate
Time frame: 36 h
Epidural medication consumption was recorded for each 4-h interval from the completion of surgery to the time that the epidural was discontinued (same as the time to achieve hospital discharge criteria). Because the discontinuation time varied from patient to patient (as they achieved physical therapy criteria), the average hourly consumption (total analgesic used divided by the total infusion time) was used as the measure of epidural drug use.
2 secondary outcomes
Neuropathic Pain (S-LANSS > 12)
Time frame: 3 and 6 months post-surgery
Knee Range of Motion (Active Flexion)
Time frame: 1-30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19910619Buvanendran A, Kroin JS, Della Valle CJ, Kari M, Moric M, Tuman KJ. Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):199-207. doi: 10.1213/ANE.0b013e3181c4273a. Epub 2009 Nov 12.
Related trials for CRPS
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CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
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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.
Asokumar Buvanendran, M.D. principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pregabalin in people with CRPS, run by Rush University Medical Center.
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 2 inclusion and 8 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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 27 Aug 2012). 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?
Epidural Medication Consumption Rate (time frame: 36 h). 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 NCT00558753, 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 26 May 2016.