NCT03364088

Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia

Completed NA Last updated 13 January 2020

What this trial tests

NA trial testing Spinal anesthesia with tourniquet in Knee Osteoarthritis in 402 participants. Completed in 3 December 2019.

Timeline

3 October 2016

Primary endpoint
22 December 2018

3 December 2019

Quick facts

Lead sponsor	Riku Antero Palanne
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	402
Start date	3 October 2016
Primary completion	22 December 2018
Estimated completion	3 December 2019
Sites	1 location across Finland

Drugs / interventions tested

• Spinal anesthesia with tourniquet
• Spinal anesthesia without tourniquet
• General anesthesia with tourniquet
• General anesthesia without tourniquet
• Oxycodone by patient-controlled analgesia (PCA) — full drug profile →

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
• Arthropathy of Knee Joint — all drugs for Arthropathy of Knee Joint →
• Knee Pain Chronic — all drugs for Knee Pain Chronic →
• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Riku Antero Palanne — full company profile →

Who can join

Adults 18 to 75, any sex, with Knee Osteoarthritis or Arthropathy of Knee Joint. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol.
   Rantasalo MT, Palanne R, Juutilainen K, Kairaluoma P, et al · · 2018 · cited 8× · PMID 30580277 · DOI 10.1136/bmjopen-2018-025546