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

NCT02501863 | Completed

• 1 other identifier: AN1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participant with side effects

  During 48 hour after operation

Study Arms (2)

Ropivacaine+fentanyl

EXPERIMENTAL

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

EXPERIMENTAL

Femoral nerve block with ropivacaine Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone.

Drug: Femoral nerve block with ropivacaine

Interventions

Femoral nerve block with ropivacaine+fentanyl DRUG

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

Also known as: RF

Ropivacaine+fentanyl

Femoral nerve block with ropivacaine DRUG

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

Also known as: R

Ropivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA PS 1 to 3 undergoing total knee arthroplasty under spinal anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Medical Center, Seoul: lead

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mijung Yun, MD, PhD

  National medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 17, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share