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

NCT ID: NCT02501863

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-08-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Ropivacaine+fentanyl

Femoral nerve block with ropivacaine+fentanyl

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

Group Type: EXPERIMENTAL

Femoral nerve block with ropivacaine+fentanyl

Intervention Type: DRUG

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

Ropivacaine

Femoral nerve block with ropivacaine

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

Group Type: EXPERIMENTAL

Femoral nerve block with ropivacaine

Intervention Type: DRUG

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

Interventions

Femoral nerve block with ropivacaine+fentanyl

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

Intervention Type: DRUG

Femoral nerve block with ropivacaine

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

Intervention Type: DRUG

Other Intervention Names

RF; R

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Center, Seoul

OTHER

Sponsor Role: lead

Responsible Party

Mija Yun, MD, PhD

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mijung Yun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National medical center

Other Identifiers

AN1

Identifier Type: -

Identifier Source: org_study_id