NCT03364088

Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia

Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia, a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Riku Antero Palanne · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Previous retrospective database studies suggest that total knee arthroplasty (TKA) surgery under spinal anesthesia has less complications than when performed under general anesthesia. In general, complications are rare and both anesthesia types are widely accepted. In Finland, total knee arthroplasty has typically been performed under spinal anesthesia. In a recent prospective randomized controlled study, total knee arthroplasty under general anesthesia resulted in less acute postoperative pain (opioid-need measured by patient-controlled anesthesia), less nausea, and faster hospital discharge than that performed under spinal anesthesia. Also the use of surgical tourniquet can affect surgical outcome: it may reduce bleeding and surgery time, but it may also cause weakness of thigh muscles and thus hinder mobilization. In a recent study, both techniques with and without surgical tourniquet appeared equal. The aims of this study are to compare total knee arthroplasty under spinal or general anesthesia, with or without surgical tourniquet, in relation to acute and chronic postoperative pain, nausea, knee function, patient reported quality of life and satisfaction on care, complications, length of stay, and need of surgical unit resources. This randomized controlled study includes 400 patients with informed consent, 18-75-years-of-age, standard primary total knee arthroplasty operation, American Society of Anesthesiologist (ASA) physical status classification I-III, body mass index under 40, and no contraindications for medications or treatments used. The hypothesis of this study are used to reassess best practices of primary total knee arthroplasty operation to enhance quality of care, patient outcomes and satisfaction, and availability of surgery due to better patient flow at surgical unit.

Conditions

• Knee Osteoarthritis
• Arthropathy of Knee Joint
• Knee Pain Chronic
• Rheumatoid Arthritis
• Anesthesia

Interventions

Type	Name	Description
PROCEDURE	Spinal anesthesia with tourniquet	Operation is done under spinal anesthesia and surgical tourniquet is used.
PROCEDURE	Spinal anesthesia without tourniquet	Operation is done under spinal anesthesia and without the use of surgical tourniquet.
PROCEDURE	General anesthesia with tourniquet	Operation is done under general anesthesia and surgical tourniquet is used.
PROCEDURE	General anesthesia without tourniquet	Operation is done under general anesthesia and without the use of surgical tourniquet.
DRUG	Oxycodone by patient-controlled analgesia (PCA)	PCA device (CADD Legacy PCA Pump, Smiths Medical, Kent, UK) is programmed to give intravenous oxycodone in doses of 0.04 mg/kg (ideal body weight). The minimum time between doses is set to 10 minutes and no more than 4 doses per hour are allowed.

Timeline

• Start date: 2016-10-03
• Primary completion: 2018-12-22
• Completion: 2019-12-03
• First posted: 2017-12-06
• Last updated: 2020-01-13

Locations

1 site across 1 country: Finland