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Status unknownNCT01457313Updated Feb 6, 2013

Pain Compared Between the First and the Second Surgery in Staged BTKA

An observational study in Knee Osteoarthritis, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2013-02-06.

Sponsored by Seoul National University Bundang Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
34
Ages
Up to 85 Years
Sex
All
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Study 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 the detailed description

postoperative pain and analgesic consumption is compared between the first and second total knee arthroplasty (TKA) operation.

02

Conditions studied

  • Knee Osteoarthritis
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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 34 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients undergoing elective bilateral staged total knee arthroplasty

Eligibility criteria

Inclusion Criteria:

  • 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.

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Study design

Time perspective
Prospective
Enrollment
34 participants (estimated)
Patient registry
No

Groups and cohorts

  • BTKA

    patients undergoing bilateral staged total knee arthroplasty

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What researchers measure

Primary outcomes

  1. VAS

    visual analogue scale

    Time frame: from the end of the TKA surgery until postoperative 48 hour

Secondary outcomes

  1. analgesic consumption

    patient controlled analgesia (fentanyl)

    Time frame: from the end of the TKA surgery until postoperative 48 hour

  2. rescue analgesic

    ketoprofen

    Time frame: from the end of the TKA surgery until postoperative 48 hour

  3. antiemetics

    antiemetics total amount

    Time frame: from the end of the TKA surgery until postoperative 48 hour

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang hopital
    Seongnam, Gyeonggi-Do 463-787, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01457313
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Kim Mihyun (Doctor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Oct 21, 2011
Start date
Oct 2011
Primary completion
Feb 2013 (estimated)
Completion
Mar 2013 (estimated)
Last update
Feb 6, 2013

Study contacts

Mihyun Kim, PhD
Contact
snmd56@yahoo.com
82-31-787-7499
Sanghwan Do, PhD
study chair · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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