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

NCT01973530 | Unknown Phase 4 DMC

• 1 other identifier: BHJRC_HK_TKR_Study_2014
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

femoral nerve block; adductor canal block; steroid; total knee replacement

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (2)

adductor canal block

ACTIVE COMPARATOR

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 femoral nerve block

OTHER

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

Interventions

adductor canal block 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)

adductor canal block

femoral nerve block 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

continuous femoral nerve block

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen Elizabeth Hospital, Hong Kong: lead

Study Sites (1)

Joint Replacement Center, Buddhist Hospital

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Eric So, FHKCA FHKAM

  Queen Elizabeth Hospital, Hospital Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric So, FHKCA FHKAM

CONTACT

29588888; sohke@ha.org.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant, Dept of Anaesthesia and Operating Services

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: October 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

HK (1)