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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Queen Elizabeth Hospital, Hong Kong
Sponsor:
Information provided by (Responsible Party):
Dr Hui Kit Man Grace, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT01973530
First received: October 25, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Procedure: adductor canal block
Procedure: femoral nerve block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Analgesic Efficacy of Continuous Femoral Nerve Block and Adductor Canal Block With Steroid Adjuvant in Patients Undergoing Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Queen Elizabeth Hospital, Hong Kong:

Primary Outcome Measures:
  • PCA morphine or pain rescuer consumption at 24h and 48h postoperative [ Time Frame: 24h and 48h postoperative ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quadriceps strength at 24h, 48h, 72h postoperative [ Time Frame: 24h, 48h, 72h postoperative ] [ Designated as safety issue: No ]
    using dynamometer (measure in Newton/centimeter square)


Secondary Outcome Measures:
  • Patient satisfaction score (0-4) [ Time Frame: upon discharge ] [ Designated as safety issue: No ]
  • Incidence of side effects and complications at postoperative day 0- 4 postoperative [ Time Frame: postoperative period 0-96 hr postoperative ] [ Designated as safety issue: Yes ]
  • Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay [ Time Frame: upon discharge ] [ Designated as safety issue: No ]
  • postoperative nausea or vomiting [ Time Frame: 0-72h ] [ Designated as safety issue: No ]
  • postoperative pruritis [ Time Frame: 0-72h ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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

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.
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973530

Contacts
Contact: Eric So, FHKCA FHKAM 29588888 sohke@ha.org.hk

Locations
Hong Kong
Joint Replacement Center, Buddhist Hospital Not yet recruiting
Kowloon, Hong Kong
Contact: Eric So, FHKCA FHKAM    29588888 ext 6202    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         
Sponsors and Collaborators
Queen Elizabeth Hospital, Hong Kong
Investigators
Principal Investigator: Eric So, FHKCA FHKAM Queen Elizabeth Hospital, Hospital Authority
  More Information

No publications provided

Responsible Party: Dr Hui Kit Man Grace, Associate Consultant, Dept of Anaesthesia and Operating Services, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT01973530     History of Changes
Other Study ID Numbers: BHJRC_HK_TKR_Study_2014
Study First Received: October 25, 2013
Last Updated: September 8, 2014
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Queen Elizabeth Hospital, Hong Kong:
femoral nerve block
adductor canal block
steroid
total knee replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014