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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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
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.
- Conditions
- Analgesia in Total Knee Arthroplasty
- 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 group | Role | What they receive |
|---|---|---|
| Continuous femoral and single shot sciatic nerve block | Active comparator | Will 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 catheters | Experimental | Patients 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.
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)
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.
- First posted7 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Principal Investigator left institution--no subjects completed the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia in Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center
- Responsible party
- Sponsor
- Investigators
- Hana Teissler, MD, Principal investigator, Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El PasoJohn Zaki, MD, Principal investigator, Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01680692
- Acronym / sponsor ID
- E12094
- Conditions
- Analgesia in Total Knee Arthroplasty
- Keywords
- Analgesia TKA, Total knee arthroplasty, Continuous femoral catheter, Continuous tibial catheter, Single shot sciatic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left institution--no subjects completed the study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Sep 2012 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous femoral and single shot sciatic nerve block | Active comparator | Drug: Ropivicaine, Device: Continuous Femoral Nerve CatheterWill 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. |
| Continuous femoral and tibial peripheral nerve catheters | Experimental | Drug: Ropivicaine, Device: Continuous Femoral Nerve Catheter, Device: Continuous Tibial Nerve CatheterPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18-85 years old) undergoing elective total knee arthroplasty's
- American Society of Anesthesiology Classification (ASA) 1, 2, or 3
Key exclusion criteria (9 listed)
- Patient refusal
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 |
|---|---|---|
| RopivicaineInfusion of local anesthetic for post-operative analgesia. | Drug | Continuous femoral and single shot sciatic nerve block, Continuous femoral and tibial peripheral nerve catheters |
| Continuous Femoral Nerve CatheterAlso: Continous femoral nerve catheter infusionContinuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively. | Device | Continuous femoral and single shot sciatic nerve block, Continuous femoral and tibial peripheral nerve catheters |
| Continuous Tibial Nerve CatheterAlso: Continuous tibial nerve catheter infusionContinuous infusion of local anesthetic delivered through a tibial nerve catheter post-operatively. | Device | Continuous femoral and tibial peripheral nerve catheters |
Primary outcome
Post-Operative Analgesia
Time frame: Patients pain score will be evaluated after surgery until discharge, an average of 3 to 4 days.
Will measure pain using visual analog scale.
1 secondary outcome
Foot Drop
Time frame: Evaluated in the first 24, 48, 72 hours prior to discharge.
Results and safety
The study was stopped early (reason given: Principal Investigator left institution--no subjects completed the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Related InfoLink provided by the sponsor.
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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.
Hana Teissler, MD principal investigator
Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso
John Zaki, MD principal investigator
Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso
1 site in 1 country: see every site and its status.
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.