AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
Show all 12Show fewer
  • 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.

Hae Wone Chang, M.D contact

82-031-787-7499

chelenh@gmail.com

South Korea1 site, 1 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.

    Recruiting

Other trials in South Korea

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 groups in NCT02007850
Study groupRoleWhat they receive
ropivacaine continuous modePlacebo comparator0.2% 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 modeActive comparator0.2% 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.

  1. Change of quadriceps muscle strength

    maximum voluntary isometric contraction of quadriceps femoris with hand held manometry

    Measured: Baseline, Postoperative 2nd day

Secondary outcomes (4)
  1. sensory changes in femoral nerve distribution

    tolerance to transcutaneous electrical stimulation

    Measured: postoperative 2 day

  2. pain scores

    verbal numeric pain scale (0-100) resting/dynamic

    Measured: postoperative 1 day

  3. pain scores

    verbal numeric pain scale (0-100) resting/dynamic

    Measured: postoperative 2 day

  4. 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.

  1. First posted11 Dec 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionFeb 2015 (estimated)
  4. Study completionJul 2015 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in