Postoperative Complications Following Total Knee Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Comparison of Effects of Combined Spinoepidural and General Anesthesia Effects on Incidence of Postoperative Complications Following Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746444
• Other study ID #: 1001201311
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: December 25, 2018

Study information

• Verified date: November 2018
• Source: Ufuk University
• Contact: Perihan Ekmekçi, MD
• Phone: +903122044000
• Email: erdogduperi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of combined spinoepidural and general anesthesia on the incidence of postoperative complications following total knee arthroplasty

Description:

Total knee arthroplasty is known to cause complications (pulmonary thromboembolism, acute kidney injury, arryhthmias and infection). The investigators aimed to study the effects of two different anesthesia techniques, i.e. combined spinoepidural anesthesia and general anesthesia on the incidence of postoperative complications such as arrhythmia, pulmonary thrombeoembolism, infection, acute kidney injury and mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 25, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients scheduled to undergo elective unilateral total knee arthroplasty

Exclusion Criteria:

• Patient refusal

• Scheduled for bilateral or unilateral unicondylar knee arthroplasty

• Known history of allergy to drugs used in the study

• Severe systemic disease

• Morbid obesity (BMI>30)

• History of renal dysfunction

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Postoperative Complications

Intervention

Other:
• General Anesthesia
The patients in general anesthesia group will undergo general anesthesia
• Regional Anesthesia
The patients in Group R will be given combined spinoepidural anesthesia

Locations

Country	Name	City	State
Turkey	Ufuk University Dr. Ridvan Ege Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Memtsoudis SG, Sun X, Chiu YL, Stundner O, Liu SS, Banerjee S, Mazumdar M, Sharrock NE. Perioperative comparative effectiveness of anesthetic technique in orthopedic patients. Anesthesiology. 2013 May;118(5):1046-58. doi: 10.1097/ALN.0b013e318286061d. Erratum in: Anesthesiology. 2016 Sep;125(3):610. — View Citation

Stundner O, Chiu YL, Sun X, Mazumdar M, Fleischut P, Poultsides L, Gerner P, Fritsch G, Memtsoudis SG. Comparative perioperative outcomes associated with neuraxial versus general anesthesia for simultaneous bilateral total knee arthroplasty. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):638-44. doi: 10.1097/AAP.0b013e31826e1494. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury	Number of participants with new onset acute kidney injury	Postoperative first day
Primary	Acute Kidney Injury	Number of participants with new onset acute kidney injury	Postoperative sixth week
Primary	Pulmonary Thromboembolism	Number of participants with new onset pulmonary thromboembolism	Postoperative first day
Primary	Pulmonary Thromboembolism	Number of participants with new onset pulmonary thromboembolism	Postoperative sixth week
Primary	Infection	Number of participants with new onset infection	Postoperative first day
Primary	Infection	Number of participants with new onset infection	Postoperative sixth week
Primary	Arryhthmia	Number of participants with new onset arryhthmia requiring treatment	Postoperative first day
Primary	Arryhthmia	Number of participants with new onset arryhthmia requiring treatment	Postoperative sixth week
Primary	Death	Number of participants with mortality	Postoperative first day
Primary	Death	Number of participants with mortality	Postoperative sixth week