Knee OsteoarthritisNCT01457313
Pain Compared Between the First and the Second Surgery in Staged BTKA
An observational study of Knee Osteoarthritis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
postoperative pain and analgesic consumption between the first and the second surgery would be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA). Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Mar 2013
- Phase
- Observational
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing elective bilateral staged total knee arthroplasty
Who may be able to join
- patients undergoing elective bilateral staged total knee arthroplasty at a 1-week interval under spinal anesthesia,
- age <=85
- American Society of Anesthesiologists physical status of I to II
- Exclusion Criteria: any contraindication to spinal anesthesia or femoral nerve block such as coagulopathy; conversion to general anesthesia; preexisting pain syndrome; abnormal liver function or renal test results; severe heart, liver, or renal disease; history of stroke or neurologic deficits; psychiatric disorder; chronic opioid use; drug dependency; allergy to study medications; inflammatory joint disease; previous surgery on or trauma of the knee; difference in preoperative VAS score of ≥ 20 (at rest and at maximum knee flexion) between each side of the knee; body mass index of ≥ 40 kg/m2; and inability to comprehend the VAS or to use patient-controlled analgesia (PCA.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang hopital
Seongnam-si, Gyeonggi-do, 463-787
About this study
Official title: Comparison of Postoperative Pain in the First and Second Knee in Staged Bilateral Total Knee Arthroplasty: Clinical Evidence That Central Sensitization Increases Systemic Pain Sensitivity
postoperative pain and analgesic consumption between the first and the second surgery would be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA).
Read the detailed description
postoperative pain and analgesic consumption is compared between the first and second total knee arthroplasty (TKA) operation.
- Conditions
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BTKA | patients undergoing bilateral staged total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
visual analogue scale
Measured: from the end of the TKA surgery until postoperative 48 hour
Secondary outcomes (3)
analgesic consumption
patient controlled analgesia (fentanyl)
Measured: from the end of the TKA surgery until postoperative 48 hour
rescue analgesic
ketoprofen
Measured: from the end of the TKA surgery until postoperative 48 hour
antiemetics
antiemetics total amount
Measured: from the end of the TKA surgery until postoperative 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Mihyun, Seoul National University Bundang Hospital
- Investigators
- Sanghwan Do, PhD, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457313
- Sponsor's protocol ID
- TKA bilat pain
- Status last verified
- Feb 2013
- First submitted
- 19 Oct 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain in the First and Second Knee in Staged Bilateral Total Knee Arthroplasty: Clinical Evidence That Central Sensitization Increases Systemic Pain Sensitivity
- ClinicalTrials.gov ID
- NCT01457313
- Acronym / sponsor ID
- TKA bilat pain
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 21 Oct 2011 (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.
postoperative pain and analgesic consumption between the first and the second surgery would be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA).
Detailed description
postoperative pain and analgesic consumption is compared between the first and second total knee arthroplasty (TKA) operation.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTKA | – | –patients undergoing bilateral staged total knee arthroplasty |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing elective bilateral staged total knee arthroplasty
Key inclusion criteria (4 listed)
- patients undergoing elective bilateral staged total knee arthroplasty at a 1-week interval under spinal anesthesia,
- age <=85
- American Society of Anesthesiologists physical status of I to II
- Exclusion Criteria: any contraindication to spinal anesthesia or femoral nerve block such as coagulopathy; conversion to general anesthesia; preexisting pain syndrome; abnormal liver function or renal test results; severe heart, liver, or renal disease; history of stroke or neurologic deficits; psychiatric disorder; chronic opioid use; drug dependency; allergy to study medications; inflammatory joint disease; previous surgery on or trauma of the knee; difference in preoperative VAS score of ≥ 20 (at rest and at maximum knee flexion) between each side of the knee; body mass index of ≥ 40 kg/m2; and inability to comprehend the VAS or to use patient-controlled analgesia (PCA.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VAS
Time frame: from the end of the TKA surgery until postoperative 48 hour
visual analogue scale
3 secondary outcomes
analgesic consumption
Time frame: from the end of the TKA surgery until postoperative 48 hour
rescue analgesic
Time frame: from the end of the TKA surgery until postoperative 48 hour
antiemetics
Time frame: from the end of the TKA surgery until postoperative 48 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
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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.
Sanghwan Do, PhD study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 4 inclusion and 0 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 6 Feb 2013. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Mihyun Kim, PhD (82-31-787-7499, snmd56@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: from the end of the TKA surgery until postoperative 48 hour). 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 6 Feb 2013.