Dexmedetomidine as Adjuvant for FNB in TKA

NCT03658421 | Completed

• 1 other identifier: [2018]45
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nerve Block; Dexmedetomidine

Keywords

femoral nerve blockade; dexmedetomidine; ropivacaine; anesthesia

Outcome Measures

Primary Outcomes (3)

• 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.

  0-72 hours postoperatively

• 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.

  0-72 hours postoperatively

• 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.

  0-72 hours postoperatively

Study Arms (3)

H group

EXPERIMENTAL

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; Device: intravenous patient-controlled analgesia pump with morphine; Procedure: Continuous femoral nerve block

L group

EXPERIMENTAL

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; Device: intravenous patient-controlled analgesia pump with morphine; Procedure: Continuous femoral nerve block

LD group

EXPERIMENTAL

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.

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

Interventions

Dexmedetomidine DRUG

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

LD group

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

Also known as: FNB

H group; L group; LD group

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.

Also known as: IV-PCA pump

H group; L group; LD group

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).

Also known as: CFNB

H group; L group; LD group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II
• scheduled for total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (2)

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

Guangzhou, Guangdong, 510000, China

Location

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

Guangzhou, Guangdong, China

Location

Related Publications (2)

• 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.

  PMID: 23161360 BACKGROUND

• 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.

  PMID: 31908520 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xia Feng, MD. Ph.D

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2018
• First Posted: September 5, 2018
• Study Start: September 1, 2018
• Primary Completion: November 5, 2018
• Study Completion: November 10, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)