Skip to main content
OpenTrials
Completed

NCT Number: NCT03364088

Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Anesthesia Arthritis Arthritis, Rheumatoid Arthropathy of Knee Joint Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Knee Pain Chronic Musculoskeletal Diseases Nausea Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Signs and Symptoms, Digestive Skin and Connective Tissue Diseases Vomiting

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Peijas hospital

Vantaa, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spinal anesthesia with tourniquet

Procedure

Operation is done under spinal anesthesia and surgical tourniquet is used.

Spinal anesthesia without tourniquet

Procedure

Operation is done under spinal anesthesia and without the use of surgical tourniquet.

General anesthesia with tourniquet

Procedure

Operation is done under general anesthesia and surgical tourniquet is used.

General anesthesia without tourniquet

Procedure

Operation is done under general anesthesia and without the use of surgical tourniquet.

Oxycodone by patient-controlled analgesia (PCA)

Drug

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.

Primary outcomes

  1. Opioid consumption

    Time frame: 24 hours postoperative

    Cumulative intravenous oxycodone consumption By patient controlled analgesia (PCA) 24 hours postoperative.

Secondary outcomes

  1. Acute postoperative pain

    Time frame: 24 hours postoperative

    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.

  2. Postoperative nausea

    Time frame: an average of 0-3 hours and 24 hours postoperative

    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.

  3. Medications given for postoperative nausea and vomiting (PONV)

    Time frame: an average of 2 to 3 days postoperative

    The number of medications given for PONV during postoperative hospital stay.

  4. Chronic postoperative pain

    Time frame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative

    Differences in Brief Pain Inventory Short Form (BPI-SF) questionnaires self-reported By patients preoperatively and 3 and 12 months postoperatively.

  5. Predictive value of chronic pain risk index

    Time frame: an average of 1-2 weeks preoperative and 24 hours, 3 months and 12 months postoperative

    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.

  6. Knee function

    Time frame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative

    Differences in Oxford knee score (OKS) questionnaires self-reported By patients preoperatively and 3 and 12 months postoperatively.

  7. Self-reported quality of life

    Time frame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative

    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.

  8. Patient satisfaction and self-reported complications

    Time frame: 3 and 12 months postoperative

    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.

  9. Times at the operation unit

    Time frame: from operating room to end of treatment in recovery room, an average of 3-5 hours

    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.

  10. Need for "rescue" analgesia

    Time frame: From recovery room to the end of hospital stay, an average of 2-3 days

    Proportion of patients needing "rescue" analgesia in form of medications and regional anesthetic techniques outside the study protocol during the postoperative hospital stay.

  11. Need for vasoactive medications, urine catheter and ventilatory support

    Time frame: intraoperative - an average of 2-3 days

    Proportion of patients needing vasoactive medications intra- or postoperatively and patients needing urine catheter or ventilatory support postoperatively.

  12. Bleeding

    Time frame: 3 months to 1 day preoperative, intraoperative, 15-24 hours postoperative

    The amount of bleeding during the operation and the change in blood hemoglobin level.

  13. Complications

    Time frame: 12 months postoperative

    Recorded complications derived from patient information systems up to 12 months postoperative.

  14. Hospital length of stay

    Time frame: an average of 2 to 3 days up to 3 months

    Time from the start of operation to the time when patient meets the hospital discharge criteria and time when patient is actually discharged.

Sponsors and collaborators

Lead sponsor

Riku Antero Palanne

Other

Collaborators

  • Finland
  • Helsinki University Central Hospital
  • University of Helsinki

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 6, 2017
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.