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Completed

NCT Number: NCT03658421

Dexmedetomidine as Adjuvant for FNB in TKA

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.

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Key information

Conditions

Nerve Block Dexmedetomidine

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine added to lower concentration of ropivacaine for postoperative analgesia in FNB

ultrasound-guided femoral nerve block

Procedure

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 names: FNB

intravenous patient-controlled analgesia pump with morphine

Device

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 names: IV-PCA pump

Continuous femoral nerve block

Procedure

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 names: CFNB

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Comparison of Dexmedetomidine as Adjuvant to Different Concentrations of Ropivacaine for Femoral Nerve Blockade in Patients Undergoing Total Knee Arthroplasty

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2018
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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