Dexmedetomidine as Adjuvant for FNB in TKA

November 15, 2018 updated by: Feng Xia, First Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University
      • Guangzhou, Guangdong, China
        • Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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.
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 Names:
  • 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 Names:
  • 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 Names:
  • CFNB
Drug: Dexmedetomidine
Dexmedetomidine added to lower concentration of ropivacaine for postoperative analgesia in FNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-72 hours postoperatively
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.
0-72 hours postoperatively
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.
0-72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Director: Xia Feng, MD. Ph.D, First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

November 5, 2018

Study Completion (Actual)

November 10, 2018

Study Registration Dates

First Submitted

September 1, 2018

First Submitted That Met QC Criteria

September 1, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2018]45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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