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Nerve BlockNCT03658421

Dexmedetomidine as Adjuvant for FNB in TKA

A study testing Dexmedetomidine, ultrasound-guided femoral nerve block and Continuous femoral nerve block in people with Nerve Block and Dexmedetomidine, run by First Affiliated Hospital, Sun Yat-Sen University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Nerve Block, Dexmedetomidine
What is being tested?
Dexmedetomidine, ultrasound-guided femoral nerve block and Continuous femoral nerve block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesChina
Study dates
1 Sep 2018to 10 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA I-II
  • scheduled for total knee arthroplasty

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

China2 sites

  • Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

  • Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
Dexmedetomidine, ultrasound-guided femoral nerve block, intravenous patient-controlled analgesia pump with morphine, Continuous femoral nerve block
Keywords
femoral nerve blockade, dexmedetomidine, ropivacaine, anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

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

  • ultrasound-guided femoral nerve blockProcedure or surgery

    Also called FNB

    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

  • intravenous patient-controlled analgesia pump with morphineDevice

    Also called IV-PCA pump

    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.

  • Continuous femoral nerve blockProcedure or surgery

    Also called CFNB

    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).

Study groups in NCT03658421
Study groupRoleWhat they receive
H groupExperimentalH 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.
Receives: Procedure: ultrasound-guided femoral nerve block; Device: intravenous patient-controlled analgesia pump with morphine; Procedure: Continuous femoral nerve block
L groupExperimentalL 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.
Receives: Procedure: ultrasound-guided femoral nerve block; Device: intravenous patient-controlled analgesia pump with morphine; Procedure: Continuous femoral nerve block
LD groupExperimentalLD 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.
Receives: Drug: Dexmedetomidine; Procedure: ultrasound-guided femoral nerve block; Device: intravenous patient-controlled analgesia pump with morphine; Procedure: Continuous femoral nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of manual muscle testing (MMT) over 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.

    Measured: 0-72 hours postoperatively

  2. Change of Timed Up and Go test (TUG) over 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.

    Measured: 0-72 hours postoperatively

  3. Change of numeric rating scales (NRS) over 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.

    Measured: 0-72 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2018
  2. Study start1 Sep 2018
  3. Primary completion5 Nov 2018
  4. Study completion10 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03658421
Sponsor's protocol ID
[2018]45
Status last verified
Nov 2018
First submitted
1 Sep 2018
Last updated
16 Nov 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.

    PubMed 23161360

  • Yang X, Kang W, Xiong W, Lu D, Zhou Z, Chen X, Zhou X, Feng X. The Effect Of Dexmedetomidine As Adjuvant To Ropivacaine 0.1% For Femoral Nerve Block On Strength Of Quadriceps Muscle In Patients Undergoing Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Trial. J Pain Res. 2019 Dec 17;12:3355-3363. doi: 10.2147/JPR.S217283. eCollection 2019.

    PubMed 31908520

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine, ultrasound-guided femoral nerve block and Continuous femoral nerve block in people with Nerve Block and Dexmedetomidine, run by First Affiliated Hospital, Sun Yat-Sen University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of manual muscle testing (MMT) over 72 hours postoperatively (time frame: 0-72 hours postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03658421, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.

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