Muscle WeaknessNCT02007850
Effect of Mode of Femoral Nerve Analgesia on Quadriceps Muscle Strength
A study testing ropivacaine in people with Muscle Weakness, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 21, or < 80 years old- men and women
- primary, unilateral total knee replacement surgery
- spinal anesthesia
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Sungnam, Gyungido, 463-707
Hae Wone Chang, MD, 82-031-787-6261, chelenh@gmail.com
Hae Wone Chang, M.D.
About this study
Official title: Effect of Continuous Femoral Analgesia on Quadriceps Muscle Strength-0.2% Ropivacaine Continuous Infusion Versus Patient Controlled Femoral Analgesia
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.
Read the 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.
- Conditions
- Muscle Weakness
- Being tested
- ropivacaine
- Keywords
- continuous femoral nerve block, knee arthroplasty, quadriceps muscle strength
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
Also called femoral nerve block
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
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine continuous mode | Placebo comparator | 0.2% ropivacaine 8 ml/hr through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl Receives: Drug: ropivacaine |
| ropivacaine patient controlled mode | Active comparator | 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 Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of quadriceps muscle strength
maximum voluntary isometric contraction of quadriceps femoris with hand held manometry
Measured: Baseline, Postoperative 2nd day
Secondary outcomes (4)
sensory changes in femoral nerve distribution
tolerance to transcutaneous electrical stimulation
Measured: postoperative 2 day
pain scores
verbal numeric pain scale (0-100) resting/dynamic
Measured: postoperative 1 day
pain scores
verbal numeric pain scale (0-100) resting/dynamic
Measured: postoperative 2 day
intravenous fentanyl consumption
cumulative fentanyl consumption on postoperative 2 day
Measured: postoperative 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hae Wone Chang, Seoul National University Hospital
- Investigators
- Hae Wone Chang, M.D., Principal investigator, Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007850
- Sponsor's protocol ID
- B-1308/214-010
- Status last verified
- Jul 2014
- First submitted
- 28 Oct 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Femoral Analgesia on Quadriceps Muscle Strength-0.2% Ropivacaine Continuous Infusion Versus Patient Controlled Femoral Analgesia
- ClinicalTrials.gov ID
- NCT02007850
- Acronym / sponsor ID
- B-1308/214-010
- Conditions
- Muscle Weakness
- Keywords
- continuous femoral nerve block, knee arthroplasty, quadriceps muscle strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine continuous mode | Placebo comparator | Drug: ropivacaine0.2% ropivacaine 8 ml/hr through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl |
| ropivacaine patient controlled mode | Active comparator | Drug: ropivacaine0.2% 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 |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 21, or < 80 years old- men and women
- primary, unilateral total knee replacement surgery
- spinal anesthesia
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaineAlso: femoral nerve blockPatients 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 | Drug | ropivacaine continuous mode, ropivacaine patient controlled mode |
Primary outcome
Change of quadriceps muscle strength
Time frame: Baseline, Postoperative 2nd day
maximum voluntary isometric contraction of quadriceps femoris with hand held manometry
4 secondary outcomes
sensory changes in femoral nerve distribution
Time frame: postoperative 2 day
pain scores
Time frame: postoperative 1 day
pain scores
Time frame: postoperative 2 day
intravenous fentanyl consumption
Time frame: postoperative 2 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hae Wone Chang, M.D. principal investigator
Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine in people with Muscle Weakness, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hae Wone Chang, M.D (82-031-787-7499, chelenh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of quadriceps muscle strength (time frame: Baseline, Postoperative 2nd day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.