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

NCT ID: NCT01973530

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-06-30

Brief Summary

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.

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

adductor canal block

Intervention Type: PROCEDURE

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)

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

Group Type: OTHER

femoral nerve block

Intervention Type: PROCEDURE

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

Interventions

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)

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr Hui Kit Man Grace

Associate Consultant, Dept of Anaesthesia and Operating Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric So, FHKCA FHKAM

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Hospital, Hospital Authority

Locations

Joint Replacement Center, Buddhist Hospital

Kowloon, , Hong Kong

Countries

Hong Kong

Central Contacts

Eric So, FHKCA FHKAM

Role: CONTACT

sohke@ha.org.hk

29588888

Facility Contacts

Eric So, FHKCA FHKAM

Role: primary

sohke@ha.org.hk

29588888 ext. 6202

Other Identifiers

BHJRC_HK_TKR_Study_2014

Identifier Type: -

Identifier Source: org_study_id