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Analgesia in Total Knee ArthroplastyEarly Phase 1NCT01680692

Continuous Femoral and Tibial Nerve Blocks in TKA Patients

A Early Phase 1 study testing Ropivicaine, Continuous Femoral Nerve Catheter and Continuous Tibial Nerve Catheter in people with Analgesia in Total Knee Arthroplasty, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate whether a new regional anesthesia technique would provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot drop after knee replacement surgery. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Analgesia in Total Knee Arthroplasty
What is being tested?
Ropivicaine, Continuous Femoral Nerve Catheter and Continuous Tibial Nerve Catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Aug 2012to Mar 2014
Phase
Early Phase 1
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 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult patients (18-85 years old) undergoing elective total knee arthroplasty's
  • American Society of Anesthesiology Classification (ASA) 1, 2, or 3

Who cannot join

  • Patient refusal
  • Under 18
  • Pregnancy
  • Presence of neurological disease or existing parasthesia
  • Diabetes
  • Chronic drug use
Show all 9Show fewer
  • Infection of leg
  • American Society of Anesthesiology Classification (ASA) 4-6 (unstable conditions)
  • History of allergy to local anesthetics or opioids

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University Medical Center of El Paso, Texas Tech University Health Sciences Center

    El Paso, Texas, 79915

Other trials in United States

About this study

Official title: A Prospective, Randomized Study Comparing Continuous Femoral and Tibial Nerve Blocks vs. Continuous Femoral and Single Shot Sciatic Nerve Block in Total Knee Arthroplasties.

The purpose of this study is to evaluate whether a new regional anesthesia technique would provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot drop after knee replacement surgery.

Read the detailed description

The aim of this study is to compare and measure the effects of Ropivicaine given through catheters located in the femoral and tibial nerves on indices of sensory blockade after total knee arthroplasties. This is a randomized, prospective study designed to address the primary research question: Does placing a continuous femoral \& tibial catheter infusion lead to superior analgesia and patient satisfaction during the entire hospital stay? The secondary research question is: Will selectively placing a continuous tibial catheter decrease the episodes of transient foot drop to zero? Investigators know from own regional institutional practices that by performing a continuous femoral with a single shot sciatic nerve block provides adequate analgesia of the entire leg, but by post-operative day 2 patient's begin to experience pain with rehabilitation and rest in the posterior-lateral aspect of the knee and leg secondary to wearing off of the sciatic nerve block anesthetic. Also, it is known that by blocking the sciatic nerve proximal to its bifurcation may lead to episodes of transient foot drop due to common peroneal nerve blockage and irritation. It is hypothesized that placement of continuous catheters in the femoral and tibial nerves would provide better analgesia and lead to no episodes of foot drop as compared to the patients that receive continuous femoral and single shot sciatic blocks.

Currently at Texas Tech Health Science Center-El Paso and University Medical Center, about 95% of patient's undergoing total knee arthroplasty's (TKAs) receives a continuous femoral infusion and a single shot sciatic with an initial bolus of 30mL (femoral) and 20mL (sciatic) of Ropivicaine 0.5% and an infusion of Ropivicaine 0.2% at a rate of 10cc/hr (usually started post-op) for at least the first 48-72 hours post-operatively. For our study, Orthopedic clinic will provide a copy of the consent form to the subject so that they can review it, and if interested in participating in the study, the patient can then contact the Principal Investigator or Study Coordinator directly. After informed consent is obtained, patients will be randomized during that time using a numbering system enclosed in sealed envelopes. Group 1 will receive a pre-operative continuous femoral catheter and a post-operative single shot sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine and 20mL (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which will be running Ropivicaine 0.2 at 10cc/hr. Group 2 will receive a pre-operative continuous femoral catheter and a post-operative continuous tibial catheter with an initial bolus of 30 mL 0.5% Ropivicaine (femoral) and 20mL 0.2% Ropivicaine (tibial), which will be followed by infusions post-operatively running at the same rate and dosage as group 1. All nerve blocks performed will be placed using a nerve stimulator (with no twitches lower than 0.2mA) under ultrasound-guidance. Proper catheter placement will be confirmed by injecting 3mL of air and visualizing by ultrasound. Once confirmed, the bolus dose as mentioned earlier of either Ropivicaine 0.5% (femoral) or 0.2% (sciatic/tibial) will be injected. All TKA cases will be performed under general anesthesia with laryngeal mask airway. Considering the fact that by placing a selective continuous tibial catheter pre-operatively, we run the risk of the catheter being the surgical field during the case. For this reason, it was decided that placement after the procedure would be best. Therefore, the patient will be taken back to the block room post-operatively and a continuous tibial nerve catheter or single shot (depending on what group assigned) will be placed and bolused using the same technique as previously described. To detect a 30% reduction in the pain score from 3-4 to a 1-2 would be required for an observed post-operative pain control difference. In order to achieve a statistically significant result to detect the previously observed difference, a sample of 38 patients in each group (total of 76) would be required. Assuming a high consent rate and given the fact many TKA's it is projected that this study can be completed in approximately 12 months.

Being tested
Ropivicaine, Continuous Femoral Nerve Catheter, Continuous Tibial Nerve Catheter
Keywords
Analgesia TKA, Total knee arthroplasty, Continuous femoral catheter, Continuous tibial catheter, Single shot sciatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivicaineDrug

    Infusion of local anesthetic for post-operative analgesia.

  • Continuous Femoral Nerve CatheterDevice

    Also called Continous femoral nerve catheter infusion

    Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.

  • Continuous Tibial Nerve CatheterDevice

    Also called Continuous tibial nerve catheter infusion

    Continuous infusion of local anesthetic delivered through a tibial nerve catheter post-operatively.

Study groups in NCT01680692
Study groupRoleWhat they receive
Continuous femoral and single shot sciatic nerve blockActive comparatorWill receive pre-operative continuous femoral catheter \& post-operative single shot sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine \& 20mL (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which will be running Ropivicaine 0.2 at 10cc/hr.
Receives: Drug: Ropivicaine; Device: Continuous Femoral Nerve Catheter
Continuous femoral and tibial peripheral nerve cathetersExperimentalPatients will receive pre-operative continuous femoral catheter \& post-operative continuous tibial catheter with an initial bolus of 30 mL 0.5% Ropivicaine (femoral) \& 20mL 0.2% Ropivicaine (tibial), which will be followed by infusions post-operatively running at 10cc/hr.
Receives: Drug: Ropivicaine; Device: Continuous Femoral Nerve Catheter; Device: Continuous Tibial Nerve Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-Operative Analgesia

    Will measure pain using visual analog scale.

    Measured: Patients pain score will be evaluated after surgery until discharge, an average of 3 to 4 days.

Secondary outcomes (1)
  1. Foot Drop

    Daily lower extremity neurological examination of the foot (specifically dorsiflexion.

    Measured: Evaluated in the first 24, 48, 72 hours prior to discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionMar 2014
  4. Study completionMar 2014

Why it stopped: Principal Investigator left institution--no subjects completed the study

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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01680692
Sponsor's protocol ID
E12094
Status last verified
Apr 2018
First submitted
29 Aug 2012
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ropivicaine, Continuous Femoral Nerve Catheter and Continuous Tibial Nerve Catheter in people with Analgesia in Total Knee Arthroplasty, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.

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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Apr 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Principal Investigator left institution--no subjects completed the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-Operative Analgesia (time frame: Patients pain score will be evaluated after surgery until discharge, an average of 3 to 4 days.). 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 25 Apr 2018.

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