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

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).

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 34

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-Do
    • Seongnam, Gyeonggi-Do, Korea, Republic of, 463-787
      • Recruiting
      • Seoul National University Bundang Hopital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergoing elective bilateral staged total knee arthroplasty

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
BTKA; patients undergoing bilateral staged total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	visual analogue scale	from the end of the TKA surgery until postoperative 48 hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Study Chair: Sanghwan Do, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 21, 2011

Study Record Updates

• Last Update Posted (Estimate): February 6, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: TKA bilat pain