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

Comparison of the Analgesic Efficacy of Continuous Femoral Nerve Block and Adductor Canal Block With Steroid Adjuvant in Patients Undergoing Total Knee Arthroplasty

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: adductor canal block; Procedure: femoral nerve block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eric So, FHKCA FHKAM; Phone Number: 29588888; Email: sohke@ha.org.hk

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Joint Replacement Center, Buddhist Hospital
    • Contact: Eric So, FHKCA FHKAM; Phone Number: 6202 29588888; Email: sohke@ha.org.hk
    • Sub-Investigator: Vincent Ho, FANZCA FHKCA
    • Sub-Investigator: Wai Hong Yuen, FHKCOS FHKAM
    • Sub-Investigator: John Wong, FHKCOS FHKAM
    • Sub-Investigator: David Chong, FHKCA FHKAM
    • Principal Investigator: Eric So, FHKCA FHKAM
    • Sub-Investigator: Loretta Leung, FHKCA FHKAM
    • Sub-Investigator: Dennis Wan, FHKCA FHKAM
    • Sub-Investigator: Grace Hui, FHKCA FHKAM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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)
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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Queen Elizabeth Hospital, Hong Kong
• Investigators: Principal Investigator: Eric So, FHKCA FHKAM, Queen Elizabeth Hospital, Hospital Authority

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Estimate): September 9, 2014
• Last Update Submitted That Met QC Criteria: September 8, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: total knee replacement; steroid; femoral nerve block; adductor canal block
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: BHJRC_HK_TKR_Study_2014