A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
epidural infusion
femoral sciatic
epidural infusion
femoral sciatic
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Yeungnam University hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
epidural infusion
femoral sciatic
Arm Description
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.
Outcomes
Primary Outcome Measures
the incidence of side effects
Side effects: The patients were asked to their experience of dizziness, sedation, nausea/vomiting (PONV), and pruritus. Urinary retention: bladder volume was measured by ultrasonography and if the volume was more than 400 mL and if the patient was unable to void spontaneously, single catheterization was performed.
Secondary Outcome Measures
Pain
Pain according to visual analogue scale at rest and on mobilization.
Motor blockade at rest and on mobilization
Motor blockade is estimated using a modified Bromage scale
Full Information
NCT ID
NCT02235506
First Posted
September 1, 2014
Last Updated
July 14, 2015
Sponsor
Yeungnam University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02235506
Brief Title
A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty
Official Title
A Comparison of Epidural Analgesia With Adding Sciatic Nerve Block to Continuous Femoral Nerve Block for Post-operative Pain Management Following Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
epidural infusion
Arm Type
Experimental
Arm Description
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,
Arm Title
femoral sciatic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
epidural infusion
Other Intervention Name(s)
continuous lumbar epidural block
Intervention Description
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
Intervention Name(s)
femoral sciatic
Other Intervention Name(s)
femoral nerve block and sciatic nerve block
Intervention Description
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
Intervention Name(s)
epidural infusion
Other Intervention Name(s)
perifix epidural catheter, B-Braoun
Intervention Description
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
Intervention Name(s)
femoral sciatic
Other Intervention Name(s)
contiplex catheter and stimuplex needle; B-Braun
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of side effects
Description
Side effects: The patients were asked to their experience of dizziness, sedation, nausea/vomiting (PONV), and pruritus. Urinary retention: bladder volume was measured by ultrasonography and if the volume was more than 400 mL and if the patient was unable to void spontaneously, single catheterization was performed.
Time Frame
during 5 days after the end of operation
Secondary Outcome Measure Information:
Title
Pain
Description
Pain according to visual analogue scale at rest and on mobilization.
Time Frame
during 5 days after the end of operation
Title
Motor blockade at rest and on mobilization
Description
Motor blockade is estimated using a modified Bromage scale
Time Frame
during 5 days after the end of operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sangjin Park, M.D.
Phone
82-53-620-3366
Email
apsj0718@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangjin Park, M.D.
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
City
Daegu
ZIP/Postal Code
705-035
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duckhee Lee, M.D.
Phone
82-53-620-3365
Email
apsj0718@naver.com
First Name & Middle Initial & Last Name & Degree
Sangjin Park, M.D.
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty
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