Comparison of Femoral Nerve Catheter and Adductor Canal Block With Steroid Adjuvant in Total Knee Replacement (TKR)

Overview

We hypothesize continuous adductor canal block with steroid adjuvant would offer no inferior analgesics and rehabilitation ability than continuous femoral nerve block for postoperative patients receiving total knee arthroplasty.

Full Title of Study: “Comparison of the Analgesic Efficacy of Continuous Femoral Nerve Block and Adductor Canal Block With Steroid Adjuvant in Patients Undergoing Total Knee Arthroplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2015

Detailed Description

A total of 80 patients who will undergo total knee arthroplasty will be randomized into two groups: Treatment groups Treatment details Femoral Group (40 patients) Continuous femoral nerve block (bolus: 0.5% Ropivacaine 10-15 ml ; infusion of 0.15 % Ropivacaine 4-6ml/h) Adductor Group (40 patients) Adductor canal block with steroid adjuvant (bolus: 0.5% Ropivacaine 10-15ml; Dexamethasone 4mg) (Total 80 patients will be recruited) – All patients will receive single shot tibial nerve block with local anaesthetics (0.5% Ropivacaine 5-8ml) before surgery for analgesia of posterior knee. – All patients will receive the same preemptive and postoperative multimodal medications for perioperative analgesia. – All groups will receive standardized method of spinal anaesthesia and standardized method of intraoperative sedation for the surgery. – Intravenous patient controlled analgesia (PCA) with morphine will be given for 48h to patient as rescue analgesia.

Interventions

  • Procedure: adductor canal block
    • Continuous adductor canal block and single shot posterior tibial nerve block under ultrasound guidance and using nerve stimulating needle (bolus: 0.5% Ropivacaine 10-15ml with dexamethasone 4mg ;with single shot posterior tibial nerve block (8-10ml 0.5% ropivacaine)
  • Procedure: femoral nerve block
    • Femoral nerve catheter inserted under ultrasound guidance using nerve stimulating needle administering ropivacaine bolus 10-15ml and infusing 0.2% ropivacaine at 4-6ml/h; plus a single shot posterior tibial nerve block under ultrasound guidance and use of nerve stimulating needle

Arms, Groups and Cohorts

  • Active Comparator: adductor canal block
    • Continuous adductor canal block and single shot posterior tibial nerve block under ultrasound guidance and using nerve stimulating needle (bolus: 0.5% Ropivacaine 10-15ml with dexamethasone 4mg ;with single shot posterior tibial nerve block (8-10ml 0.5% ropivacaine)
  • Other: continuous femoral nerve block
    • Femoral nerve catheter inserted under ultrasound guidance using nerve stimulating needle administering ropivacaine bolus 10-15ml and infusing 0.2% ropivacaine at 4-6ml/h; plus a single shot posterior tibial nerve block under ultrasound guidance and use of nerve stimulating needle

Clinical Trial Outcome Measures

Primary Measures

  • PCA morphine or pain rescuer consumption at 24h and 48h postoperative
    • Time Frame: 24h and 48h postoperative
  • Postoperative pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery
    • Time Frame: 6h,12h, 24h,48h, 72h after surgery
  • Quadriceps strength at 24h, 48h, 72h postoperative
    • Time Frame: 24h, 48h, 72h postoperative
    • using dynamometer (measure in Newton/centimeter square)

Secondary Measures

  • Patient satisfaction score (0-4)
    • Time Frame: upon discharge
  • Incidence of side effects and complications at postoperative day 0- 4 postoperative
    • Time Frame: postoperative period 0-96 hr postoperative
  • Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay
    • Time Frame: upon discharge
  • postoperative nausea or vomiting
    • Time Frame: 0-72h
  • postoperative pruritis
    • Time Frame: 0-72h
  • Haemastix on call and every 8 hours after surgery for postoperative 24hours for patients
    • Time Frame: on call and every 8 hours after surgery for postoperative 24h

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of primary osteoarthritis – Scheduled for elective total knee arthroplasty – Signed written informed consent – Planned use of spinal anaesthesia – Cognitive sound to use assessment tools Exclusion Criteria:

  • Patients refusing to give consents – Scheduled for revision total knee replacement – Patient outside range of 30 to 80 yrs old – Non-chinese population – Cognitive impairment/ inability to use the outcome assessment tools – Contraindications to regional anesthesia – severe cardiovascular disease (unstable angina, second or third degree heart block) – pre-existing neurologic disease including psychiatric disorder – drug abuser – Pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury. – Allergy or contraindication to drugs used in this study: morphine, Non-steroidal anti-inflammatory drugs (NSAID) such as ketorolac , diclofenac, dihydrocodeine, local anaesthetics (lignocaine, ropivacaine, bupivacaine), epinephrine – Moderate or severe renal impairment (serum creatinine > 160 micromol/l)

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Queen Elizabeth Hospital, Hong Kong
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Hui Kit Man Grace, Associate Consultant, Dept of Anaesthesia and Operating Services – Queen Elizabeth Hospital, Hong Kong
  • Overall Official(s)
    • Eric So, FHKCA FHKAM, Principal Investigator, Queen Elizabeth Hospital, Hospital Authority
  • Overall Contact(s)
    • Eric So, FHKCA FHKAM, 29588888, sohke@ha.org.hk

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