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Trial record 34 of 34 for:    "Collagen Disease" | "Tranexamic Acid"

Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03364088
Recruitment Status : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : January 23, 2019
Sponsor:
Collaborators:
Helsinki University Central Hospital
Helsinki University
Finland
Information provided by (Responsible Party):
Riku Antero Palanne, Helsinki University Central Hospital

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE October 1, 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
Opioid consumption [ Time Frame: 24 hours postoperative ]
Cumulative intravenous oxycodone consumption By patient controlled analgesia (PCA) 24 hours postoperative.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03364088 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Complications [ Time Frame: 12 months postoperative ]
    Recorded complications derived from patient information systems up to 12 months postoperative.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Complications [ Time Frame: 12 months postoperative ]
    Recorded complications derived from patient information systems up to 12 months postoperative.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia
Official Title  ICMJE Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia, a Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Osteoarthritis
  • Arthropathy of Knee Joint
  • Knee Pain Chronic
  • Rheumatoid Arthritis
  • Anesthesia
Intervention  ICMJE
  • Procedure: Spinal anesthesia with tourniquet
    Operation is done under spinal anesthesia and surgical tourniquet is used.
  • Procedure: Spinal anesthesia without tourniquet
    Operation is done under spinal anesthesia and without the use of surgical tourniquet.
  • Procedure: General anesthesia with tourniquet
    Operation is done under general anesthesia and surgical tourniquet is used.
  • Procedure: General anesthesia without tourniquet
    Operation is done under general anesthesia and without the use of surgical tourniquet.
  • Drug: 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.
Study Arms  ICMJE
  • Active Comparator: 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.

    Interventions:
    • Procedure: Spinal anesthesia with tourniquet
    • Drug: Oxycodone by patient-controlled analgesia (PCA)
  • Active Comparator: 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.

    Interventions:
    • Procedure: Spinal anesthesia without tourniquet
    • Drug: Oxycodone by patient-controlled analgesia (PCA)
  • Active Comparator: 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.

    Interventions:
    • Procedure: General anesthesia with tourniquet
    • Drug: Oxycodone by patient-controlled analgesia (PCA)
  • Active Comparator: 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.

    Interventions:
    • Procedure: General anesthesia without tourniquet
    • Drug: Oxycodone by patient-controlled analgesia (PCA)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 21, 2019)
402
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2017)
400
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03364088
Other Study ID Numbers  ICMJE PeijasTKA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Riku Antero Palanne, Helsinki University Central Hospital
Study Sponsor  ICMJE Riku Antero Palanne
Collaborators  ICMJE
  • Helsinki University Central Hospital
  • Helsinki University
  • Finland
Investigators  ICMJE Not Provided
PRS Account Helsinki University Central Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP