Dexmedetomidine as Adjuvant for FNB in TKA

NCT ID: NCT03658421

Last Updated: 2018-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2018-11-10

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Nerve Block Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ultrasound-guided femoral nerve block

Intervention Type 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

intravenous patient-controlled analgesia pump with morphine

Intervention Type 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.

Continuous femoral nerve block

Intervention Type 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).

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.

Group Type EXPERIMENTAL

ultrasound-guided femoral nerve block

Intervention Type 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

intravenous patient-controlled analgesia pump with morphine

Intervention Type 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.

Continuous femoral nerve block

Intervention Type 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).

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

ultrasound-guided femoral nerve block

Intervention Type 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

intravenous patient-controlled analgesia pump with morphine

Intervention Type 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.

Continuous femoral nerve block

Intervention Type 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).

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

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

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

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).

Intervention Type PROCEDURE

Other Intervention Names

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FNB IV-PCA pump CFNB

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Feng Xia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xia Feng, MD. Ph.D

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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

Guangzhou, Guangdong, China

Site Status

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 23161360 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31908520 (View on PubMed)

Other Identifiers

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[2018]45

Identifier Type: -

Identifier Source: org_study_id

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