Comparison of Continuous Femoral Nerve Block (CFNB/SA) and Continuous Femoral Nerve Block with Mini-dose Spinal Morphine (CFNB/SAMO) for Postoperative Analgesia after Total Knee Arthroplasty (TKA) (Comparison of CFNB/SA and CFNB/SAMO for Postoperative Analgesia after TKA)
Study ID: TCTR20150609003
Current status: Completed
Last Updated: June 09, 2015
Tracking Information
Date of Registration in Primary Registry: June 09, 2015
Date of First Enrollment: June 15, 2012 (Anticipated)
Target Sample Size: 68
Last Updated Date: June 09, 2015
Primary Outcome(s):
  • Outcome name: VAS pain score
       Metric/method of measurement: Interview
       Time point: Post operative 1, 6, 12, 24, 36 and 48 hours
       Safety Issue?: No


  • Key Secondary Outcomes:
  • Outcome name: Tramadol IV requirement
       Metric/method of measurement: Measurement
       Time point: Post operative 1, 6, 12, 24, 36 and 48 hours
       Safety Issue?: No


  • Outcome name: Postoperative nausea and vomiting
       Metric/method of measurement: Number of patients with outcome
       Time point: During postoperative from 1-6,6-12 and 12-24 hours
       Safety Issue?: No


  • Descriptive Information
    Public Title: Comparison of Continuous Femoral Nerve Block (CFNB/SA) and Continuous Femoral Nerve Block with Mini-dose Spinal Morphine (CFNB/SAMO) for Postoperative Analgesia after Total Knee Arthroplasty (TKA)
    Scientific Title: Comparison of Continuous Femoral Nerve Block (CFNB/SA) and Continuous Femoral Nerve Block with Mini-dose Spinal Morphine (CFNB/SAMO) for Postoperative Analgesia after Total Knee Arthroplasty (TKA) (Comparison of CFNB/SA and CFNB/SAMO for Postoperative Analgesia after TKA)
    Brief Summary: Purpose: Unsatisfactory analgesia for major knee surgery with femoral nerve block (FNB) alone was reported and the additional benefit of sciatic block to continuous femoral nerve block (CFNB) was not conclusive. The aim of the present study was to find the benefit of the additional mini-dose spinal morphine (0.035 mg) to CFNB for postoperative pain control and to compare their associated side effects after total knee arthroplasty (TKA).
    Methods: After written informed consent and with Institutional Ethics Committee approval, 68 ASA I-III patients scheduled for elective unilateral TKA under spinal anesthesia (SA) were included in the present prospective, randomized controlled study. The patients were allocated into two groups. CFNB was placed in all patients by the inguinal paravascular approach with 20 ml of 0.25% levobupivacaine. Group I (CFNB/SA), SA was administered with 2.8 ml levobupivacaine and Group II (CFNB/SAMO), SA with 2.8 ml levobupivacaine plus morphine 0.035 mg. At PACU, pain and other adverse effects were recorded. Pain was assessed by visual analog scale (VAS 0-10). Tramadol 50 mg IV was given if the VAS > 4. In the ward, all patients were maintained by continuous femoral infusion of 0.125% levobupivacaine rate 7 ml/hr and then reduced to 5 ml/hr if VAS is not higher than 3.
    Detailed Description: The aim of the present study was to find the benefit of the additional mini-dose spinal morphine (0.035 mg) to CFNB for postoperative pain control and to compare their associated side effects after total knee arthroplasty (TKA). After written informed consent and with Institutional Ethics Committee approval, 68 ASA I-III patients scheduled for elective unilateral TKA under spinal anesthesia (SA) were included. The patients were allocated into two groups. CFNB was placed in all patients by the inguinal paravascular approach with 20 ml of 0.25% levobupivacaine. Group I (CFNB/SA), SA was administered with 2.8 ml levobupivacaine and Group II (CFNB/SAMO), SA with 2.8 ml levobupivacaine plus morphine 0.035 mg. At PACU, pain and other adverse effects were recorded. Pain was assessed by visual analog scale (VAS 0-10). Tramadol 50 mg IV was given if the VAS > 4. In the ward, all patients were maintained by continuous femoral infusion of 0.125% levobupivacaine rate 7 ml/hr and then reduced to 5 ml/hr if VAS is not higher than 3.
    Study Design: Allocation: Randomized controlled trial
    Control: Active
    Study Endpoint Classification: Efficacy Study
    Intervention Model: Parallel
    Number of Arms: 2
    Masking: Open Label (Masked Roles: Subject)
    Primary Purpose: Treatment
    Study Phase: Phase 2
    Health Condition(s) or Problem(s) Studied: Total Knee Arthroplasty
    Study Arms:
  • Arm: 1
  • Intervention Name: Continuous Femoral Nerve Block
    Type: Active Comparator
    Classification: Procedure/Surgery
    Descriptions: Continuous Femoral Nerve Block
  • Arm: 2
  • Intervention Name: Continuous Femoral Nerve Block with Mini-dose Spinal Morphine
    Type: Active Comparator
    Classification: Procedure/Surgery
    Descriptions: Continuous Femoral Nerve Block with Mini-dose Spinal Morphine
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 68
    Study Start Date (First enrollment): June 15, 2012
    Primary Completion Date: May 15, 2013
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 40 Years : Maximum 80 Years
    ASA I-III patients scheduled for elective unilateral TKA under spinal anesthesia (SA)
    Exclusion Criteria
    age 40 years or 80 years
    body mass index BMI 45
    renal insufficiency Cr 1 5 mg dl
    pre existing neurological deficit
    inability to comprehend pain scales
    chronic opioid use
    contraindications to either neuraxial block or FNB
    Accept Healthy Volunteers: Yes
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Petchara Sundarathiti
    Degree: M.D.
    Phone: 66 2201 1523
    Email: petcharas@gmail.com
    Postal Address: 270 Rama VI rd., Ratchathewi, Bangkok, Thailand 10400
    State/Province: Bangkok        Postal Code: 10400
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20150609003
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: Faculty of Medicine Ramathibodi Hospital, Mahidol University
    Study Primary Sponsor: Faculty of Medicine Ramathibodi Hospital, Mahidol University
    Study Secondary Sponsor: 1.) Faculty of Medicine Ramathibodi Hospital, Mahidol University
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Petchara Sundarathiti
    Degree: M.D.
    Phone: 66 2201 1523
    Email: petcharas@gmail.com
    Postal Address: 270 Rama VI rd., Ratchathewi, Bangkok, Thailand 10400
    State/Province: Bangkok        Postal Code: 10400
    Country: Thailand
    Track changes

    Copyright  © 2009. Medical Research Foundation, Thailand. All Rights Reserved.