Clinical trial NCT03658421: Dexmedetomidine as Adjuvant for FNB in TKA
Official title: Comparison of Dexmedetomidine as Adjuvant to Different Concentrations of Ropivacaine for Femoral Nerve Blockade in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Dexmedetomidine
Keywords: femoral nerve blockade
dexmedetomidine
ropivacaine
anesthesia
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of manual muscle testing (MMT) over 72 hours postoperatively
timeFrame: 0-72 hours postoperatively
measure: Change of Timed Up and Go test (TUG) over 72 hours postoperatively
timeFrame: 0-72 hours postoperatively
measure: Change of numeric rating scales (NRS) over 72 hours postoperatively
timeFrame: 0-72 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xia Feng, MD. Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.