Dexmedetomidine as Adjuvant for FNB in TKA

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658421
• Other study ID #: [2018]45
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: November 10, 2018

Study information

• Verified date: November 2018
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 10, 2018
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dexmedetomidine
• Nerve Block

Intervention

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

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

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.

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).

Locations

Country	Name	City	State
China	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	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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