Motor-sparing analgesic interventions for patients undergoing total knee arthroplasty (TKA) are a key component of fast-track surgery. The investigators want to estimate treatments effects, inclusion rate, and feasibility of conducting a future randomized controlled superiority trial and to assess whether the short-term postoperative analgesic effect and ambulation after a Genicular - Infiltration Between Popliteal Artery and Capsule of Knee (iPACK) block in patients undergoing unilateral primary TKA is superior to Femoral triangle - iPACK block and Local Infiltration Analgesia (LIA). The study is a prospective, double-blind, triple-arm superiority pilot randomised controlled trial with a randomization rate 1:1:1.Group I will receive a Genicular - iPACK block, group II a Femoral Triangle - iPACK block and group III LIA. The primary study outcome is the proportion of patients that are able to mobilise (defined as walk 10 meters with assistance) with a numerical rating scale (NRS) of equal or less than 4 without the use of opioids at 4-6 hours after TKA. Secondary outcomes are efficacy (measured in NRS, total morphine consumption, total morphine titrations), functionality (quadriceps strength, timed-up-and-go, 6-minute walk test, inpatient falls), frequency of opioid related adverse events, discharge readiness, patient satisfaction, health-related quality of life, length of stay (LOS), complications after TKA and adverse events related to the study interventions.
Total knee arthroplasty (TKA) is one of the most frequently performed orthopedic surgical procedures for the treatment of osteoarthritis of the knee. Fast-tract recovery protocols emphasize the importance of early mobilization and physiotherapy to improve functional recovery, reduce postoperative complications, and decrease the economic burden of TKA. As the patients having TKA typically have severe pain postoperatively, multimodal analgesic regimen in many institutions includes interventional analgesia modality, such as nerve blocks, to facilitate early mobilization. At this time however, no universal recommendation exists on what constitutes the optimal nerve block technique that provides favorable balance between motor sparing for ambulation and analgesia. Various motor-sparing nerve blocks (e.g., femoral triangle block, adductor canal block, obturator nerve blocks, Infiltration Between Popliteal Artery and Capsule of Knee (iPACK), genicular nerve block and Local Infiltration Analgesia (LIA)) are viable options for interventional analgesia in patients undergoing TKA. By this study in patients having TKA, the investigators aim to compare the analgesia and ambulation between the genicular nerve block iPACK versus Femoral triangle nerve block + iPACK versus LIA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Group 1: Genicular nerve block-iPACK group (performed by anaesthesiologist) Method: Ultrasound and nerve stimulation guided injection Drug: a total of 30 ml of ropivacaine 0,5% (150 mg) will be used
Group 2: Femoral triangle block-iPACK group (performed by anaesthesiologist) Method: Ultrasound and nerve stimulation guided injection Drug: a total of 30 ml of ropivacaine 0,5% (150 mg) will be used
Group 3: LIA (performed by surgeon) Method: Blind injection Drug: a total of 200ml of 0.2% ropivacaine will be used (400mg). Of this, 150ml of ropivacaine 0.2% will be mixed with 1mg of adrenaline.
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Pain assessed by NRS at rest and movement: 4 -6 hours after TKA
The main study outcome is the proportion of patients that have a numeral rating scale (NRS) \<4 during mobilization without morphine at 4-6 hours after TKA. Mobilisation will be defined as walking 10 meters with walking aids or an assistant. NRS is a unidimensional, subjective measurement of pain intensity, expressed by the patient as a number between 0 and 10. It is a 11 point scale in which 0 equals no pain and 10 maximal pain. NRS at rest will also be determined
Time frame: 4 to 6 hours after TKA
Pain assessed by NRS
NRS is determined at rest and movement at 24 hours, 48 hours, 72 hours and 1 month after TKA. NRS is a unidimensional, subjective measurement of pain intensity, expressed by the patient as a number between 0 and 10. It is a 11 point scale in which 0 equals no pain and 10 maximal pain.
Time frame: 24 hours, 48 hours, 72 hours and 1 month
Post-operative morphine consumption and titration
The amount of morphine that the patient demanded and that was given will be determined at 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Time frame: 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Quadriceps strength pre-and post operative
quadriceps strength measured in maximum voluntary isometric contraction (MVIC) at baseline (pre-operative), 4-6 hours, 24 hours, 48 hours after TKA
Time frame: baseline, 4-6 hours, 24 hours, and 48 hours after TKA
6-minute walking test pre-and post operative
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6 minute walking test will be performed at baseline (pre-operative), 24 hours, 48 hours and 72 hours after TKA
Time frame: baseline, 24 hours, 48 hours and 72 hours after TKA
Timed up and go pre- and post operative
In the timed up and go test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The results are expressed in minutes or seconds. The timed up and go test will be performed at baseline (pre-operative), 24 hours, 48 hours and 72 hours after TKA
Time frame: baseline, 24 hours, 48 hours and 72 hours after TKA
Health status assessed by WOMAC: pre- and post-operative
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with osteoarthritis of the knee. The test questions are scored on a scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. The questionnaire will be performed at baseline (pre-operative) and 1 month after TKA
Time frame: baseline and 1 month after TKA
The change in health-related quality of life assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire
The EQ-5D-5L is a patient-reported generic measure of HRQoL comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses to the 5 items (one for each dimension) result in a patient's health state that can be transformed into a utility score ranging between 0 (death) and 1 (full health), representing the quality of life of the health state.
Time frame: baseline and 1 month after TKA
Assessment of anxiety and depression by the Hospital Anxiety and Depression Scale (HADS) questionnaire
HADS is developed to detect anxiety and depression in patients with physical health problems. The questionnaire consists of 14 items: 7 items to measure anxiety and 7 items to measure depression
Time frame: baseline and 1 month after TKA
Measurement of patient satisfaction by the patient satisfaction scale
The patient satisfaction scale is measured in a 5-point Likert scale with response categories consisting of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very dissatisfied
Time frame: 72 hours and 1 month after TKA
Assessment of pain experience by the Pain Catastrophizing Scale (PCS)
The PCS is often used in clinical settings to measure catastrophic thinking related to pain. The 13 item questionnaire consists of 3 subscales (magnification, rumination and helplessness) and asks patients to reflect on past painful experiences and to indicate the degree on which they experiences each of 13 thoughts of feelings on a 5- point scale (0 not at all and 4 all the time).
Time frame: baseline and 1 month after TKA
Nerve block time
(time from first needle insertion to final needle exit)
Time frame: per-operative
Number and type of complications of TKA
Complications of TKA (e.g., transfusions, prevalence of venous thrombo-embolic event, infection…) will be assessed per - and post-operative
Time frame: Through study completion, up to 1 month after randomisation and study intervention
Discharge readiness
The discharge readiness will be compared between the three groups. Discharge readiness is assessed by means of the following: * Pain is under control (\<4) with oral painkillers * Wound is dry (not purulent) * Knee flexion is possible over 70 degrees * Patients are self-sustainable with crutches The discharge readiness is described as yes or no.
Time frame: Through study completion, up to 1 month after randomisation
Length of stay
The length of stay will be compared between the three groups by counting the number of days in the hospital
Time frame: Through study completion, up to 1 month after randomisation
Number of hospital readmissions (due to knee related problems at 1 month)
The readmission status of patients will be compared between groups after 1 month of TKA.
Time frame: 1 month after TKA
Safety assessment by reporting adverse events
Throughout the study, adverse events related to the intervention will be collected.
Time frame: Through study completion, up to 1 month after randomisation
Frequency of opioid related adverse event
The frequency of opioid related adverse event will be assessed from the start of surgery until 72 hours after TKA
Time frame: 0 hours, 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Attributable mortality during the trial
Mortality which is attributable to study interventions, surgical procedure, underlying condition or other relevant reasons will be investigated during the trial (perioperative, until discharge)
Time frame: during hospitalisation, an average of 3 days
Inpatient fall
The risk of inpatient fall will be assessed during hospital stay.
Time frame: during hospitalisation, an average of 3 days
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