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

• Conditions: Knee Osteoarthritis

• Registration Number: NCT01457313
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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).

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-06
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS	from the end of the TKA surgery until postoperative 48 hour	visual analogue scale

Secondary Outcome Measures

Name	Time	Method
analgesic consumption	from the end of the TKA surgery until postoperative 48 hour	patient controlled analgesia (fentanyl)
rescue analgesic	from the end of the TKA surgery until postoperative 48 hour	ketoprofen
antiemetics	from the end of the TKA surgery until postoperative 48 hour	antiemetics total amount

Trial Locations

Locations (1)

Seoul National University Bundang hopital; 🇰🇷 Seongnam, Gyeonggi-Do, Korea, Republic of