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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01457313
• Other study ID #: TKA bilat pain
• Status: Recruiting
• Phase: N/A
• First received: October 19, 2011
• Last updated: February 4, 2013
• Start date: October 2011
• Est. completion date: March 2013

Study information

• Verified date: February 2013
• Source: Seoul National University Bundang Hospital
• Contact: Mihyun Kim, PhD
• Phone: 82-31-787-7499
• Email: snmd56[@]yahoo.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang hopital	Seongnam	Gyeonggi-Do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	visual analogue scale	from the end of the TKA surgery until postoperative 48 hour	No
Secondary	analgesic consumption	patient controlled analgesia (fentanyl)	from the end of the TKA surgery until postoperative 48 hour	No
Secondary	rescue analgesic	ketoprofen	from the end of the TKA surgery until postoperative 48 hour	No
Secondary	antiemetics	antiemetics total amount	from the end of the TKA surgery until postoperative 48 hour	No