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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
402
Operation is done under spinal anesthesia and surgical tourniquet is used.
Operation is done under spinal anesthesia and without the use of surgical tourniquet.
Operation is done under general anesthesia and surgical tourniquet is used.
Operation is done under general anesthesia and without the use of surgical tourniquet.
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.
Helsinki University Central Hospital, Peijas hospital
Vantaa, Finland
Opioid consumption
Cumulative intravenous oxycodone consumption By patient controlled analgesia (PCA) 24 hours postoperative.
Time frame: 24 hours postoperative
Acute postoperative pain
Patient reported pain (supine at rest, with knee straight and hip in 45 degrees flexion, with knee at 45 degrees flexion and after walking 5 meters) by numerical rating scale (NRS; a whole number from 0 to10 where 0 = no pain and 10 = worst possible pain) 24 hours postoperative.
Time frame: 24 hours postoperative
Postoperative nausea
Patient reported nausea by numerical rating scale (NRS; a whole number from 0 to10 where 0 = no nausea and 10 = worst possible nausea) before transferring from recovery room to surgical ward and 24 hours postoperative.
Time frame: an average of 0-3 hours and 24 hours postoperative
Medications given for postoperative nausea and vomiting (PONV)
The number of medications given for PONV during postoperative hospital stay.
Time frame: an average of 2 to 3 days postoperative
Chronic postoperative pain
Differences in Brief Pain Inventory Short Form (BPI-SF) questionnaires self-reported By patients preoperatively and 3 and 12 months postoperatively.
Time frame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
Predictive value of chronic pain risk index
4 out of 5 risk factors described by Althaus et al. are asked during preoperative visit and 1 out of 5 risk factors will be assessed 24 hours postoperative. These results will be compared to results from BPI-SF questionnaires.
Time frame: an average of 1-2 weeks preoperative and 24 hours, 3 months and 12 months postoperative
Knee function
Differences in Oxford knee score (OKS) questionnaires self-reported By patients preoperatively and 3 and 12 months postoperatively.
Time frame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
Self-reported quality of life
Differences in 15-dimensional, generic, standardized, self-administered measure of health-related quality of life (15D) questionnaires self-reported by patients preoperatively and 3 and 12 months postoperatively.
Time frame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
Patient satisfaction and self-reported complications
A patient-reported outcome measures (PROM) questionnaire made for this study including 10 questions about patient satisfaction and possible complications at 3 and 12 months postoperatively.
Time frame: 3 and 12 months postoperative
Times at the operation unit
Time (in minutes) spent for managing anesthesia and surgery, in the operating room and in the recovery room. Information is gathered from electrical anesthesia management program.
Time frame: from operating room to end of treatment in recovery room, an average of 3-5 hours
Need for "rescue" analgesia
Proportion of patients needing "rescue" analgesia in form of medications and regional anesthetic techniques outside the study protocol during the postoperative hospital stay.
Time frame: From recovery room to the end of hospital stay, an average of 2-3 days
Need for vasoactive medications, urine catheter and ventilatory support
Proportion of patients needing vasoactive medications intra- or postoperatively and patients needing urine catheter or ventilatory support postoperatively.
Time frame: intraoperative - an average of 2-3 days
Bleeding
The amount of bleeding during the operation and the change in blood hemoglobin level.
Time frame: 3 months to 1 day preoperative, intraoperative, 15-24 hours postoperative
Complications
Recorded complications derived from patient information systems up to 12 months postoperative.
Time frame: 12 months postoperative
Hospital length of stay
Time from the start of operation to the time when patient meets the hospital discharge criteria and time when patient is actually discharged.
Time frame: an average of 2 to 3 days up to 3 months
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