Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia

NCT ID: NCT03364088

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-03
• Study Completion Date: 2019-12-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spinal anesthesia with tourniquet

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.

Group Type: ACTIVE_COMPARATOR

Spinal anesthesia with tourniquet

Intervention Type: PROCEDURE

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

Oxycodone by patient-controlled analgesia (PCA)

Intervention Type: 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.

Spinal anesthesia without tourniquet

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.

Group Type: ACTIVE_COMPARATOR

Spinal anesthesia without tourniquet

Intervention Type: PROCEDURE

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

Oxycodone by patient-controlled analgesia (PCA)

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

General anesthesia with tourniquet

Intervention Type: PROCEDURE

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

Oxycodone by patient-controlled analgesia (PCA)

Intervention Type: 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 without tourniquet

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.

Group Type: ACTIVE_COMPARATOR

General anesthesia without tourniquet

Intervention Type: PROCEDURE

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

Oxycodone by patient-controlled analgesia (PCA)

Intervention Type: 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.

Interventions

Spinal anesthesia with tourniquet

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

Intervention Type: PROCEDURE

Spinal anesthesia without tourniquet

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

Intervention Type: PROCEDURE

General anesthesia with tourniquet

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

Intervention Type: PROCEDURE

General anesthesia without tourniquet

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

Intervention Type: PROCEDURE

Oxycodone by patient-controlled analgesia (PCA)

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

Finland

UNKNOWN

Sponsor Role: collaborator

Riku Antero Palanne

OTHER

Sponsor Role: lead

Responsible Party

Riku Antero Palanne

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Helsinki University Central Hospital, Peijas hospital

Vantaa, , Finland

Countries

Finland

References

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.

Reference Type: BACKGROUND

PMID: 22337572 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30580277 (View on PubMed)

Other Identifiers

PeijasTKA

Identifier Type: -

Identifier Source: org_study_id