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Dexmedetomidine as Adjuvant for FNB in TKA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03658421
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Feng Xia, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
The aim of the study was to find out whether addition of dexmedetomidine to lower concentration of ropivacaine preoperatively in femoral nerve block (FNB) would intensify analgesia and preserve quadriceps muscle strength after TKA.

Condition or disease Intervention/treatment Phase
Nerve Block Dexmedetomidine Drug: Dexmedetomidine Procedure: ultrasound-guided femoral nerve block Device: intravenous patient-controlled analgesia pump with morphine Procedure: Continuous femoral nerve block Not Applicable

Detailed Description:
We designed this study to evaluate whether dexmedetomidine added to lower concentration of ropivacaine for FNB can intensify analgesic effect and meanwhile reduce the possibility of lower limb (or quadriceps) weakness. Three groups were compared: 0.2% ropivacaine (H group), 0.1% ropivacaine (L group) and ropivacaine 0.1% added with 2 μg/kg dexmedetomidine (LD group).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Dexmedetomidine as Adjuvant to Different Concentrations of Ropivacaine for Femoral Nerve Blockade in Patients Undergoing Total Knee Arthroplasty
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : November 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: H group
H group stands for High concentration group. A single bolous of 20 ml ropivacaine 0.2% in ultrasound-guided femoral nerve block (FNB) before the TKA surgery, followed by continuous femoral nerve block (CFNB) using ropivacaine 0.2% (5 ml/h) for postoperative analgesia which started right after surgery. After surgery, all patients received multimodal analgesia of 200mg celecoxib every 12 hours. All subjects received anothother intravenous patient-controlled analgesia pump (IV-PCA pump), which included 50 mg morphine in 50 ml saline: bolus 2 mg; lock out time, 15 minutes.
Procedure: ultrasound-guided femoral nerve block
ultrasound-guided femoral nerve block, a single bolous of 20 ml ropivacaine (concentration 0.2% for H group or 0.1% for L group) before surgery followed by continuous femoral nerve block using an infusion rate of ropivacaine 0.2% 5 ml/h for postoperative analgesia started right after surgery
Other Name: FNB

Device: intravenous patient-controlled analgesia pump with morphine
All subjects received intravenous patient-controlled analgesia (IV-PCA) pumps to measure additional morphine consumption, which included 50 mg morphine in 50 ml saline: bolus 2 mg; lock out time, 15 minutes.
Other Name: IV-PCA pump

Procedure: Continuous femoral nerve block
All the continuous femoral nerve block infusion regimes in the pump were connected to CFNB catheter, which contained only ropivacaine with different concentrations (ropivacaine 0.1% for L group and LD group; ropivacaine 0.2% for H group, 5 ml/h).
Other Name: CFNB

Experimental: L group
L group stands for low concentration group. A single bolous of 20 ml ropivacaine 0.1% in ultrasound-guided femoral nerve block (FNB) before the TKA surgery, followed by continuous femoral nerve block (CFNB) using ropivacaine 0.1% (5 ml/h) for postoperative analgesia which started right after surgery. All subjects received anothother intravenous patient-controlled analgesia pump (IV-PCA pump), which included 50 mg morphine in 50 ml saline: bolus 2 mg; lock out time, 15 minutes.
Procedure: ultrasound-guided femoral nerve block
ultrasound-guided femoral nerve block, a single bolous of 20 ml ropivacaine (concentration 0.2% for H group or 0.1% for L group) before surgery followed by continuous femoral nerve block using an infusion rate of ropivacaine 0.2% 5 ml/h for postoperative analgesia started right after surgery
Other Name: FNB

Device: intravenous patient-controlled analgesia pump with morphine
All subjects received intravenous patient-controlled analgesia (IV-PCA) pumps to measure additional morphine consumption, which included 50 mg morphine in 50 ml saline: bolus 2 mg; lock out time, 15 minutes.
Other Name: IV-PCA pump

Procedure: Continuous femoral nerve block
All the continuous femoral nerve block infusion regimes in the pump were connected to CFNB catheter, which contained only ropivacaine with different concentrations (ropivacaine 0.1% for L group and LD group; ropivacaine 0.2% for H group, 5 ml/h).
Other Name: CFNB

Experimental: LD group
LD group stands for low concentration group with dexmedetomidine. A single bolous of 20 ml ropivacaine 0.1% plus 2 μg/kg dexmedetomidine in ultrasound-guided femoral nerve block (FNB) before the TKA surgery, followed by continuous femoral nerve block (CFNB) using ropivacaine 0.1% (5 ml/h) for postoperative analgesia which started right after surgery. All subjects received anothother intravenous patient-controlled analgesia pump (IV-PCA pump), which included 50 mg morphine in 50 ml saline: bolus 2 mg; lock out time, 15 minutes.
Drug: Dexmedetomidine
Dexmedetomidine added to lower concentration of ropivacaine for postoperative analgesia in FNB

Procedure: ultrasound-guided femoral nerve block
ultrasound-guided femoral nerve block, a single bolous of 20 ml ropivacaine (concentration 0.2% for H group or 0.1% for L group) before surgery followed by continuous femoral nerve block using an infusion rate of ropivacaine 0.2% 5 ml/h for postoperative analgesia started right after surgery
Other Name: FNB

Device: intravenous patient-controlled analgesia pump with morphine
All subjects received intravenous patient-controlled analgesia (IV-PCA) pumps to measure additional morphine consumption, which included 50 mg morphine in 50 ml saline: bolus 2 mg; lock out time, 15 minutes.
Other Name: IV-PCA pump

Procedure: Continuous femoral nerve block
All the continuous femoral nerve block infusion regimes in the pump were connected to CFNB catheter, which contained only ropivacaine with different concentrations (ropivacaine 0.1% for L group and LD group; ropivacaine 0.2% for H group, 5 ml/h).
Other Name: CFNB




Primary Outcome Measures :
  1. Change of manual muscle testing (MMT) over 72 hours postoperatively [ Time Frame: 0-72 hours postoperatively ]
    The MMT grading was recorded from 0 to 5 to measure muscle strength at 6, 12, 24, 36, 48 and 72 hours after surgery.

  2. Change of Timed Up and Go test (TUG) over 72 hours postoperatively [ Time Frame: 0-72 hours postoperatively ]
    TUG test was used to assess the patient's mobility that requires both balance and static. It was measured at 24, 48 and 72 hours after surgery.

  3. Change of numeric rating scales (NRS) over 72 hours postoperatively [ Time Frame: 0-72 hours postoperatively ]
    NRS was used to evaluate postoperative pain control. They were measured at 6, 12, 24, 36, 48 and 72 hours after surgery.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II
  • scheduled for total knee arthroplasty

Exclusion Criteria:

  • refusal to participate in this study
  • unicompartmental knee arthroplasty
  • BMI > 35 kg/m2
  • congnitive or phychiatric history
  • refusal of general anesthesia
  • contraindication to laryngeal mask airway insertion
  • contraindication to peripheral nerve block (localized infections, sepsis, coagulopathy, bleeding diathesis or preexisting lower extremity neurological abnormality)
  • allergy to the drugs used

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): NCT03658421


Locations
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China, Guangdong
Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Director: Xia Feng, MD. Ph.D First Affiliated Hospital, Sun Yat-Sen University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Feng Xia, Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03658421    
Other Study ID Numbers: [2018]45
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Feng Xia, First Affiliated Hospital, Sun Yat-Sen University:
femoral nerve blockade
dexmedetomidine
ropivacaine
anesthesia
Additional relevant MeSH terms:
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Morphine
Dexmedetomidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action