Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia

NCT03364088 | Completed

• 1 other identifier: PeijasTKA
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

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

  24 hours postoperative

Secondary Outcomes (14)

• Acute postoperative pain

  24 hours postoperative

• Postoperative nausea

  an average of 0-3 hours and 24 hours postoperative

• Medications given for postoperative nausea and vomiting (PONV)

  an average of 2 to 3 days postoperative

• Chronic postoperative pain

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

• Predictive value of chronic pain risk index

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

Study Arms (4)

Spinal anesthesia with tourniquet

ACTIVE COMPARATOR

This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet (with the pressure of 250 mmHg or \> 100 mmHg higher than systolic blood pressure) is used during the operation. Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of the tourniquet. Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.

Procedure: Spinal anesthesia with tourniquet; Drug: Oxycodone by patient-controlled analgesia (PCA)

Spinal anesthesia without tourniquet

ACTIVE COMPARATOR

This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet is not used during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation. Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.

Procedure: Spinal anesthesia without tourniquet; Drug: Oxycodone by patient-controlled analgesia (PCA)

General anesthesia with tourniquet

ACTIVE COMPARATOR

This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) and surgical tourniquet (with the pressure of 250 mmHg or \> 100 mmHg higher than systolic blood pressure) is used during the operation. Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of tourniquet. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins. Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.

Procedure: General anesthesia with tourniquet; Drug: Oxycodone by patient-controlled analgesia (PCA)

General anesthesia without tourniquet

ACTIVE COMPARATOR

This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) without the use of surgical tourniquet. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins. Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.

Procedure: General anesthesia without tourniquet; Drug: Oxycodone by patient-controlled analgesia (PCA)

Interventions

Spinal anesthesia with tourniquet PROCEDURE

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

Spinal anesthesia with tourniquet

Spinal anesthesia without tourniquet PROCEDURE

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

Spinal anesthesia without tourniquet

General anesthesia with tourniquet PROCEDURE

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

General anesthesia with tourniquet

General anesthesia without tourniquet PROCEDURE

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

General anesthesia without 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.

General anesthesia with tourniquet; General anesthesia without tourniquet; Spinal anesthesia with tourniquet; Spinal anesthesia without tourniquet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riku Antero Palanne: lead
• Helsinki University Central Hospital: collaborator
• University of Helsinki: collaborator
• Finland: collaborator

Study Sites (1)

Helsinki University Central Hospital, Peijas hospital

Vantaa, 00029, Finland

Location

Related Publications (2)

• 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.

  PMID: 22337572 BACKGROUND

• 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.

  PMID: 30580277 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis, Rheumatoid; Pain; Postoperative Nausea and Vomiting

Interventions

Anesthesia, Spinal; Tourniquets; Anesthesia, General

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: December 6, 2017
• Study Start: October 3, 2016
• Primary Completion: December 22, 2018
• Study Completion: December 3, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

FI (1)