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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Femoral nerve block with ropivacaine+fentanyl; Drug: Femoral nerve block with ropivacaine

• Registration Number: NCT02501863
• Lead Sponsor: National Medical Center, Seoul

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Study Start: 2015-10
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine+fentanyl	Femoral nerve block with ropivacaine+fentanyl	Femoral nerve block with ropivacaine+fentanyl Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone.
Ropivacaine	Femoral nerve block with ropivacaine	Femoral nerve block with ropivacaine Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone.

Primary Outcome Measures

Name	Time	Method
Pain on the VAS(Visual Analog Scale)	During 48 hour after operation	VAS(resting, movement) at operation day, postoperation 1 day, postoperation 2 day.

Secondary Outcome Measures

Name	Time	Method
Number of participant with side effects	During 48 hour after operation