Analgesic Effect of Ropivacaine Plus Fentanyl vs Ropivacaine for Continuous 3-in-1 FNB After Total Knee Arthroplasty

Study Overview
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Brief Summary
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The postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty.

Detailed Description
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Forty patients of American Society of Anesthesiologist physical status Ⅰor Ⅱ undergoing total knee arthroplasty under spinal anesthesia would be enrolled and randomly divided into two groups (R, 3-in-1 using a 30 ml of ropivacaine 0.375% and a continuous 3-in-1 with a ropivacaine 0.2%(8mL/h) for 48 h after operation, RF: Fifty ug of fentanyl will be added to a bolus(30ml ropivacaine 0.375%) and 1ug/ml of fentanyl will be mixed to a continuous infusion(8mg/h, ropivacaine 0.2%). Spinal anesthesia will be done after the insertion of femoral catheter. IV PCA with hydromorphone(0.15mg/ml, 0-1-10), will be used for rescue analgesics. Visual analgesia scale, hydromorphone consumption, side effects until 48h after operation and satisfaction will be compared.

Official Title
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Analgesic Effect of Ropivacaine Plus Fentanyl vs Ropivacaine for Continuous 3-in-1 FNB After Total Knee Arthroplasty

Conditions
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Pain

Intervention / Treatment
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* Drug: Femoral nerve block with ropivacaine+fentanyl
* Drug: Femoral nerve block with ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA PS 1 to 3 undergoing total knee arthroplasty under spinal anesthesia Exclusion Criteria: Patients were excluded from this study if they had contraindications to a regional anesthetic technique (e. g., local infection, sepsis, coagulation abnormality), allergy to local anesthetic or fentanyl, preexisting neurologic deficit in the lower extremities, and inability to comprehend the pain scales or use IV patient-controlled analgesia (PCA) device.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine+fentanyl<br>Femoral nerve block with ropivacaine+fentanyl Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone. | Drug: Femoral nerve block with ropivacaine+fentanyl<br>* Ropivacaine+fentanyl are used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone<br>* Other names: RF;|
| Experimental: Ropivacaine<br>Femoral nerve block with ropivacaine Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone. | Drug: Femoral nerve block with ropivacaine<br>* Ropivacaine is used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone<br>* Other names: R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on the VAS(Visual Analog Scale) | VAS(resting, movement) at operation day, postoperation 1 day, postoperation 2 day. | During 48 hour after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant with side effects |  | During 48 hour after operation |