A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty

NCT ID: NCT02235506

Last Updated: 2015-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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The investigators compared continuous epidural infusion with combined continuous femoral and single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation indices.

Detailed Description

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The parcicipants were randomly assingned to epidural infusion group and femoral sciatic block. In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation. In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. The incidence of side effects is measured.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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epidural infusion

In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation,

Group Type EXPERIMENTAL

epidural infusion

Intervention Type PROCEDURE

Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.

epidural infusion

Intervention Type DEVICE

Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.

femoral sciatic

In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr.

Group Type EXPERIMENTAL

femoral sciatic

Intervention Type PROCEDURE

After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.

femoral sciatic

Intervention Type DEVICE

After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.

Interventions

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epidural infusion

Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.

Intervention Type PROCEDURE

femoral sciatic

After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.

Intervention Type PROCEDURE

epidural infusion

Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.

Intervention Type DEVICE

femoral sciatic

After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.

Intervention Type DEVICE

Other Intervention Names

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continuous lumbar epidural block femoral nerve block and sciatic nerve block perifix epidural catheter, B-Braoun contiplex catheter and stimuplex needle; B-Braun

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists Physical Status Classification I-II
* total knee arthroplasty
* 18-90 years

Exclusion Criteria

* allergic to the local anesthetics
* cognitive impairment such as dementia
* coagulopathy
* motor and sensory impairment
* patient refusal
* BMI \>39
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sangjin Park

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sangjin Park, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Locations

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Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sangjin Park, M.D.

Role: CONTACT

82-53-620-3366

Facility Contacts

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Duckhee Lee, M.D.

Role: primary

82-53-620-3365

Other Identifiers

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apsj0901

Identifier Type: -

Identifier Source: org_study_id

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