Analgesic Effect of Ropivacaine Plus Fentanyl vs Ropivacaine for Continuous 3-in-1 FNB After Total Knee Arthroplasty

Overview

The postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: July 2016

Detailed Description

Forty patients of American Society of Anesthesiologist physical status Ⅰor Ⅱ undergoing total knee arthroplasty under spinal anesthesia would be enrolled and randomly divided into two groups (R, "3-in-1" using a 30 ml of ropivacaine 0.375% and a continuous 3-in-1 with a ropivacaine 0.2%(8mL/h) for 48 h after operation, RF: Fifty ug of fentanyl will be added to a bolus(30ml ropivacaine 0.375%) and 1ug/ml of fentanyl will be mixed to a continuous infusion(8mg/h, ropivacaine 0.2%). Spinal anesthesia will be done after the insertion of femoral catheter. IV PCA with hydromorphone(0.15mg/ml, 0-1-10), will be used for rescue analgesics. Visual analgesia scale, hydromorphone consumption, side effects until 48h after operation and satisfaction will be compared.

Interventions

  • Drug: Femoral nerve block with ropivacaine+fentanyl
    • Ropivacaine+fentanyl are used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone
  • Drug: Femoral nerve block with ropivacaine
    • Ropivacaine is used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone

Arms, Groups and Cohorts

  • Experimental: Ropivacaine+fentanyl
    • Femoral nerve block with ropivacaine+fentanyl Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone.
  • Experimental: Ropivacaine
    • Femoral nerve block with ropivacaine Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone.

Clinical Trial Outcome Measures

Primary Measures

  • Pain on the VAS(Visual Analog Scale)
    • Time Frame: During 48 hour after operation
    • VAS(resting, movement) at operation day, postoperation 1 day, postoperation 2 day.

Secondary Measures

  • Number of participant with side effects
    • Time Frame: During 48 hour after operation

Participating in This Clinical Trial

Inclusion Criteria

  • ASA PS 1 to 3 undergoing total knee arthroplasty under spinal anesthesia Exclusion Criteria:

  • Patients were excluded from this study if they had contraindications to a regional anesthetic technique (e. g., local infection, sepsis, coagulation abnormality), allergy to local anesthetic or fentanyl, preexisting neurologic deficit in the lower extremities, and inability to comprehend the pain scales or use IV patient-controlled analgesia (PCA) device.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Medical Center, Seoul
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mija Yun, MD, PhD, Anesthesiologist – National Medical Center, Seoul
  • Overall Official(s)
    • Mijung Yun, MD, PhD, Principal Investigator, National Medical Center

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