Clinical trial NCT03364088: Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia
Official title: Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Arthropathy of Knee Joint
Knee Pain Chronic
Rheumatoid Arthritis
Anesthesia
Keywords: Total knee arthroplasty
Anesthesia
Surgical tourniquet
Pain
Postoperative nausea and vomiting
Quality of life
Length of stay
Knee function
Bioelectrical impedance
Knee endoprosthesis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: University of Helsinki
name: Finland
First posted: 2017-12-06
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Indication for total knee arthroplasty exists (patient has osteoarthritis, rheumatoid arthritis or other disease affecting knee joint that does not respond to conservative treatment)
* Patient understands the study information and is willing to participate
* Triathlon endoprosthesis is suitable for patient
* ASA Physical Status Classification 1-3
* Patient will be operated by a surgeon who has done at least 100 total knee arthroplasty procedures with Triathlon endoprosthesis before

Exclusion Criteria:

* BMI \> 40 kg/m2
* ASA Physical Status Classification \> 3
* Valgus or varus \> 15° degrees in the knee that will be operated
* Extension deficit ≥ 20° or flexion ≤ 90° in the knee that will be operated
* Earlier major (open) surgery in the knee that will be operated
* Contraindication for drugs used in the study
* Contraindication for either spinal or general anesthesia
* Glomerular filtration rate \< 60ml/min/1.73m2 (by Chronic Kidney DIsease Epidemiology Collaboration formula)
* Known or suspected disease affecting the function of liver
* Preoperative use of strong opioids
* Patient is pregnant, cognitively disabled, under guardianship, a prisoner or in compulsory military service
* Patient will be operated by a surgeon who has done less than 100 total knee arthroplasty procedures before or by a surgeon who does not operate with Triathlon endoprosthesis
* Day of the surgery is not suitable for study (no research personnel available for 24 hours postoperative evaluation)

Primary outcomes:
measure: Opioid consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Acute postoperative pain
timeFrame: 24 hours postoperative
measure: Postoperative nausea
timeFrame: an average of 0-3 hours and 24 hours postoperative
measure: Medications given for postoperative nausea and vomiting (PONV)
timeFrame: an average of 2 to 3 days postoperative
measure: Chronic postoperative pain
timeFrame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
measure: Predictive value of chronic pain risk index
timeFrame: an average of 1-2 weeks preoperative and 24 hours, 3 months and 12 months postoperative
measure: Knee function
timeFrame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
measure: Self-reported quality of life
timeFrame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
measure: Patient satisfaction and self-reported complications
timeFrame: 3 and 12 months postoperative
measure: Times at the operation unit
timeFrame: from operating room to end of treatment in recovery room, an average of 3-5 hours
measure: Need for "rescue" analgesia
timeFrame: From recovery room to the end of hospital stay, an average of 2-3 days
measure: Need for vasoactive medications, urine catheter and ventilatory support
timeFrame: intraoperative - an average of 2-3 days
measure: Bleeding
timeFrame: 3 months to 1 day preoperative, intraoperative, 15-24 hours postoperative
measure: Complications
timeFrame: 12 months postoperative
measure: Hospital length of stay
timeFrame: an average of 2 to 3 days up to 3 months
Other outcomes:
Locations:
city: Vantaa
country: Finland
facility: Helsinki University Central Hospital, Peijas hospital
Study officials:
References:
citation: Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
citation: Rantasalo MT, Palanne R, Juutilainen K, Kairaluoma P, Linko R, Reponen E, Helkamaa T, Vakkuri A, Olkkola KT, Madanat R, Skants NKA. Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol. BMJ Open. 2018 Dec 22;8(12):e025546. doi: 10.1136/bmjopen-2018-025546.