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

September 13, 2016 updated by: Mija Yun, MD, PhD, National Medical Center, Seoul
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine+fentanyl

Femoral nerve block with ropivacaine+fentanyl

Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone.
Drug: Femoral nerve block with ropivacaine+fentanyl
Ropivacaine+fentanyl are used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone
Other Names:
  • RF
Experimental: Ropivacaine

Femoral nerve block with ropivacaine

Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone.
Drug: Femoral nerve block with ropivacaine
Ropivacaine is used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone
Other Names:
  • R

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During 48 hour after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participant with side effects
Time Frame: During 48 hour after operation
During 48 hour after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Medical Center, Seoul

Investigators

  • Principal Investigator: Mijung Yun, MD, PhD, National medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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