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Dexmedetomidine as Adjuvant for FNB in TKA

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Sun Yat-sen University

Status

Completed

Conditions

Dexmedetomidine
Nerve Block

Treatments

Drug: Dexmedetomidine
Procedure: ultrasound-guided femoral nerve block
Procedure: Continuous femoral nerve block
Device: intravenous patient-controlled analgesia pump with morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT03658421
[2018]45

Details and patient eligibility

About

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.

Full 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).

Enrollment

90 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 3 patient groups

H group
Experimental group
Description:
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.
Treatment:
Device: intravenous patient-controlled analgesia pump with morphine
Procedure: Continuous femoral nerve block
Procedure: ultrasound-guided femoral nerve block
L group
Experimental group
Description:
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.
Treatment:
Device: intravenous patient-controlled analgesia pump with morphine
Procedure: Continuous femoral nerve block
Procedure: ultrasound-guided femoral nerve block
LD group
Experimental group
Description:
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.
Treatment:
Drug: Dexmedetomidine
Device: intravenous patient-controlled analgesia pump with morphine
Procedure: Continuous femoral nerve block
Procedure: ultrasound-guided femoral nerve block

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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