Dexmedetomidine as Adjuvant for FNB in TKA

Not Applicable

Completed

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

• Registration Number: NCT03658421
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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).

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-01
• Study First Submitted QC: 2018-09-01
• Study First Posted: 2018-09-05
• Status Verified: 2018-11
• Primary Completion: 2018-11-05
• Study Completion: 2018-11-10
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• ASA I-II
• scheduled for total knee arthroplasty

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
H group	intravenous patient-controlled analgesia pump with morphine	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.
H group	Continuous femoral nerve block	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.
LD group	ultrasound-guided femoral nerve block	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.
L group	Continuous femoral nerve block	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.
H group	ultrasound-guided femoral nerve block	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.
L group	intravenous patient-controlled analgesia pump with morphine	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.
LD group	Continuous femoral nerve block	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.
L group	ultrasound-guided femoral nerve block	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.
LD group	intravenous patient-controlled analgesia pump with morphine	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.
LD group	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Change of manual muscle testing (MMT) over 72 hours postoperatively	0-72 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.
Change of numeric rating scales (NRS) over 72 hours postoperatively	0-72 hours postoperatively	NRS was used to evaluate postoperative pain control. They were measured at 6, 12, 24, 36, 48 and 72 hours after surgery.
Change of Timed Up and Go test (TUG) over 72 hours postoperatively	0-72 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.

Trial Locations

Locations (1)

Department of Anesthesiology, First affiliated hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China