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OpenTrials
Completed

NCT Number: NCT02501863

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Femoral nerve block with ropivacaine+fentanyl

Drug

Ropivacaine+fentanyl are used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone

Other names: RF

Femoral nerve block with ropivacaine

Drug

Ropivacaine is used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone

Other names: R

Primary outcomes

  1. Pain on the VAS(Visual Analog Scale)

    Time frame: During 48 hour after operation

    VAS(resting, movement) at operation day, postoperation 1 day, postoperation 2 day.

Secondary outcomes

  1. Number of participant with side effects

    Time frame: During 48 hour after operation

Sponsors and collaborators

Lead sponsor

National Medical Center, Seoul

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 17, 2015
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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