Genicular Nerve Block Versus Femoral Triangle Nerve Block Versus LIA for Postoperative Analgesia After Total Knee Arthroplasty: A Pilot Randomized Controlled Superiority Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Analgesia
- Sponsor
- Ziekenhuis Oost-Limburg
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Pain assessed by NRS at rest and movement: 4 -6 hours after TKA
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Thibaut Vanneste
Principal Investigator
Ziekenhuis Oost-Limburg
Eligibility Criteria
Inclusion Criteria
- •≥18 years of age at screening
- •Scheduled to undergo elective primary unilateral TKA
- •American Society of Anaesthesiologists (ASA) physical status 1, 2 or 3
- •Mentally competent to provide informed consent, to report pain intensity and to use patient-controlled analgesia
- •Physically able to perform independently the baseline functionality tests
Exclusion Criteria
- •Obesity (BMI\>40)
- •Previous open knee surgery
- •Revision TKA or bilateral TKA
- •Contraindication to the following study medication: ropivacaine, morphine, midazolam, ketorolac, propofol, remifentanil, clonidine, dexamethasone, acetaminophen
- •Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
- •Chronic widespread pain
- •Radicular pain in index legClinical Study Protocol Version 1.0
- •Preoperative strong opioid use within 3 days before surgery (with the exception of weak opioids: tramadol and codeine)
- •Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity
- •Impaired kidney function (Chronic kidney disease (CKD) G4-G5 according to Kidney Disease: Improving Global Outcomes (KDIGO) classification)
Outcomes
Primary Outcomes
Pain assessed by NRS at rest and movement: 4 -6 hours after TKA
Time Frame: 4 to 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
Secondary Outcomes
- Pain assessed by NRS(24 hours, 48 hours, 72 hours and 1 month)
- Quadriceps strength pre-and post operative(baseline, 4-6 hours, 24 hours, and 48 hours after TKA)
- Assessment of anxiety and depression by the Hospital Anxiety and Depression Scale (HADS) questionnaire(baseline and 1 month after TKA)
- Nerve block time(per-operative)
- Number and type of complications of TKA(Through study completion, up to 1 month after randomisation and study intervention)
- Discharge readiness(Through study completion, up to 1 month after randomisation)
- Number of hospital readmissions (due to knee related problems at 1 month)(1 month after TKA)
- Attributable mortality during the trial(during hospitalisation, an average of 3 days)
- Measurement of patient satisfaction by the patient satisfaction scale(72 hours and 1 month after TKA)
- Assessment of pain experience by the Pain Catastrophizing Scale (PCS)(baseline and 1 month after TKA)
- Length of stay(Through study completion, up to 1 month after randomisation)
- Safety assessment by reporting adverse events(Through study completion, up to 1 month after randomisation)
- Post-operative morphine consumption and titration(4-6 hours, 24 hours, 48 hours and 72 hours after TKA)
- 6-minute walking test pre-and post operative(baseline, 24 hours, 48 hours and 72 hours after TKA)
- Health status assessed by WOMAC: pre- and post-operative(baseline and 1 month after TKA)
- Inpatient fall(during hospitalisation, an average of 3 days)
- Timed up and go pre- and post operative(baseline, 24 hours, 48 hours and 72 hours after TKA)
- The change in health-related quality of life assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire(baseline and 1 month after TKA)
- Frequency of opioid related adverse event(0 hours, 4-6 hours, 24 hours, 48 hours and 72 hours after TKA)