Effect of Mode of Femoral Nerve Analgesia on Quadriceps Muscle Strength
Primary Purpose
Muscle Weakness
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Weakness focused on measuring continuous femoral nerve block, knee arthroplasty, quadriceps muscle strength
Eligibility Criteria
Inclusion Criteria:
- > 21, or < 80 years old- men and women
- primary, unilateral total knee replacement surgery
- spinal anesthesia
Exclusion Criteria:
- general anesthesia
- secondary knee replacement surgery
- patient refusal for continuous femoral nerve analgesia technique
- abnormal coagulation profile, e.g. Prothrombin time international normalized ratio > 1.5, activated partial thrombin time > 50 sec
- within 5 days after termination oral antiplatelet agent
- Body mass index>45
- impaired renal function
- infection near femoral area
- previous injury near femoral area
- neurologic dysfunction in lower limb
- previous adverse drug reaction for local anesthetics
- American society of anesthesiologists (ASA) class III, iV or V
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
ropivacaine continuous mode
ropivacaine patient controlled mode
Arm Description
0.2% ropivacaine 8 ml/hr through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl
0.2% ropivacaine patient controlled mode, basal rate 4 ml/hr, bolus 4 ml, lockout 60 minutes through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl
Outcomes
Primary Outcome Measures
Change of quadriceps muscle strength
maximum voluntary isometric contraction of quadriceps femoris with hand held manometry
Secondary Outcome Measures
sensory changes in femoral nerve distribution
tolerance to transcutaneous electrical stimulation
pain scores
verbal numeric pain scale (0-100) resting/dynamic
pain scores
verbal numeric pain scale (0-100) resting/dynamic
intravenous fentanyl consumption
cumulative fentanyl consumption on postoperative 2 day
Full Information
NCT ID
NCT02007850
First Posted
October 28, 2013
Last Updated
July 29, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02007850
Brief Title
Effect of Mode of Femoral Nerve Analgesia on Quadriceps Muscle Strength
Official Title
Effect of Continuous Femoral Analgesia on Quadriceps Muscle Strength-0.2% Ropivacaine Continuous Infusion Versus Patient Controlled Femoral Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Quadriceps muscle strength is an important determinant of quality of recovery in elderly patients after total knee arthroplasty. We try to compare the quadriceps muscle strength change between 0.2 % ropivacaine continuous fixed femoral infusion and patient controlled femoral analgesia group.
Detailed Description
Continuous femoral nerve analgesia technique is relatively safe, can be easily trained, and reduces significantly intravenous opioid consumption. These favorable features make it standard treatment option for postoperative knee pain. However, direct perineural local anesthetic effect is not only confined into pain fiber, but, the other sensory and motor nerve fibers. Therefore, unwanted motor weakness is accompanied. Quadriceps muscle strength, which is important determinant of physical function after knee arthroplasty, can be influenced in continuous femoral nerve block. Various local anesthetic infusion techniques have been suggested to minimize the change of quadriceps muscle strength. Decreasing local anesthetic concentrations affect not only degree of muscle weakness, but also reduces the quality of pain control. Different anatomic location of catheter tip, considering motor fiber in posterior part of femoral nerve, could not reduce motor weakness. In a study with continuous popliteal-sciatic nerve blocks after hallux valgus repair, repeated bolus administration seems to be more effective method for pain control without concurrent motor impairment. However, another study with continuous femoral nerve block in healthy volunteers, hourly repeated bolus dose of 5 ml of 0.1% ropivacaine failed to spare motor block. Previously, our institution standard technique is fixed continuous infusion of 0.2% ropivacaine and concomitant intravenous patient controlled fentanyl. Because physical therapy of our institution, usually starts with the 2nd day of operation, so, we assume that continuous fixed infusion may result in more drug accumulation near nerve fiber. So, patient controlled mode of femoral analgesia could be better choice for initiation of physical therapy. At the same time, comparison between patient controlled analgesia and continuous infusion is not fully elucidated until recently. Therefore, in this study, we try to compare quadriceps muscle strength change between continuous infusion and patient controlled femoral analgesia in patients undergoing total knee replacement arthroplasty. Secondary outcomes include sensory effect in femoral nerve distribution, pain scores, iv fentanyl consumption, and other adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
continuous femoral nerve block, knee arthroplasty, quadriceps muscle strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ropivacaine continuous mode
Arm Type
Placebo Comparator
Arm Description
0.2% ropivacaine 8 ml/hr through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl
Arm Title
ropivacaine patient controlled mode
Arm Type
Active Comparator
Arm Description
0.2% ropivacaine patient controlled mode, basal rate 4 ml/hr, bolus 4 ml, lockout 60 minutes through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Other Intervention Name(s)
femoral nerve block
Intervention Description
Patients receive 15 ml of 0.25% ropivacaine pre-operatively through femoral block catheter, followed by 0.2% ropivacaine continuous mode or patient controlled mode for 2 days after surgery
Primary Outcome Measure Information:
Title
Change of quadriceps muscle strength
Description
maximum voluntary isometric contraction of quadriceps femoris with hand held manometry
Time Frame
Baseline, Postoperative 2nd day
Secondary Outcome Measure Information:
Title
sensory changes in femoral nerve distribution
Description
tolerance to transcutaneous electrical stimulation
Time Frame
postoperative 2 day
Title
pain scores
Description
verbal numeric pain scale (0-100) resting/dynamic
Time Frame
postoperative 1 day
Title
pain scores
Description
verbal numeric pain scale (0-100) resting/dynamic
Time Frame
postoperative 2 day
Title
intravenous fentanyl consumption
Description
cumulative fentanyl consumption on postoperative 2 day
Time Frame
postoperative 2 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 21, or < 80 years old- men and women
primary, unilateral total knee replacement surgery
spinal anesthesia
Exclusion Criteria:
general anesthesia
secondary knee replacement surgery
patient refusal for continuous femoral nerve analgesia technique
abnormal coagulation profile, e.g. Prothrombin time international normalized ratio > 1.5, activated partial thrombin time > 50 sec
within 5 days after termination oral antiplatelet agent
Body mass index>45
impaired renal function
infection near femoral area
previous injury near femoral area
neurologic dysfunction in lower limb
previous adverse drug reaction for local anesthetics
American society of anesthesiologists (ASA) class III, iV or V
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hae Wone Chang, M.D
Phone
82-031-787-7499
Email
chelenh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hae Wone Chang, M.D.
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Sungnam
State/Province
Gyungido
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hae Wone Chang, MD
Phone
82-031-787-6261
Email
chelenh@gmail.com
First Name & Middle Initial & Last Name & Degree
Hae Wone Chang, M.D.
12. IPD Sharing Statement
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Effect of Mode of Femoral Nerve Analgesia on Quadriceps Muscle Strength
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