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

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ClinicalTrials.gov Identifier: NCT02501863
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Mija Yun, MD, PhD, National Medical Center, Seoul

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Femoral nerve block with ropivacaine+fentanyl Drug: Femoral nerve block with ropivacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Analgesic Effect of Ropivacaine Plus Fentanyl vs Ropivacaine for Continuous 3-in-1 FNB After Total Knee Arthroplasty
Study Start Date : October 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Ropivacaine+fentanyl

Femoral nerve block with ropivacaine+fentanyl

Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone.

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

Experimental: Ropivacaine

Femoral nerve block with ropivacaine

Interventions: Femoral nerve catheter insertion, 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
Other Name: R




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of participant with side effects [ Time Frame: During 48 hour after operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501863


Sponsors and Collaborators
National Medical Center, Seoul
Investigators
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Principal Investigator: Mijung Yun, MD, PhD National Medical Center
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Responsible Party: Mija Yun, MD, PhD, Anesthesiologist, National Medical Center, Seoul
ClinicalTrials.gov Identifier: NCT02501863    
Other Study ID Numbers: AN1
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fentanyl
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local