Total Knee ArthroplastyPhase 4NCT02223364
Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)
A Phase 4 study testing Peripheral nerve blocks with Bupivacaine, Intra articular injection with Ropivacaine and Intra articular injection with liposomal bupivacaine in people with Total Knee Arthroplasty, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to find a better way to make patients comfortable after their knee surgery. The investigators compared three ways of providing pain relief, either by use of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the surgical joint area with one of two different… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Peripheral nerve blocks with Bupivacaine, Intra articular injection with Ropivacaine and Intra articular injection with liposomal bupivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- Patients presenting for unilateral primary total knee replacement.
- No focal neurologic deficit of the surgical lower extremity.
- Cognitively intact with the ability to sign informed consent
Who cannot join
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
- Body mass index (BMI) > 40 kg/m2
- Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib
- Major systemic medical problems such as:
- Severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
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- Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
- Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
- Impaired cognitive function or inability to understand the study protocol
- Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >1.5], refusal, etc.).
- Previous contralateral knee replacement managed with regional or periarticular injection
- Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
- Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Prospective, Randomized, Controlled Trial Comparing Continuous Femoral and Single Injection Sciatic Peripheral Nerve Blocks vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel) on Patients Undergoing Total Knee Arthroplasty
The purpose of this study is to find a better way to make patients comfortable after their knee surgery. The investigators compared three ways of providing pain relief, either by use of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the surgical joint area with one of two different medicines, either ropivacaine or liposomal bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic nerve areas would result in lower pain scores and opioid consumption than either of the two injections in the surgical joint area.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Peripheral nerve blocks with Bupivacaine, Intra articular injection with Ropivacaine, Intra articular injection with liposomal bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve blocks with BupivacaineDrug
Also called Marcaine, Sensorcaine
Subjects received Bupivacaine 0.5% preoperatively, then Bupivacaine 0.2% upon post anesthesia care unit (PACU) arrival via femoral nerve block, then Bupivacaine 0.25% via single-injection sciatic nerve.
Intra articular injection with RopivacaineDrug
Also called Naropin
Subjects received an intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Ropivacaine dose depended upon body weight: 50-74.9 kg: 200 mg, 75-99.9 kg: 300 mg, 100-125 kg: 400 mg.
Intra articular injection with liposomal bupivacaineDrug
Also called Exparel
Subjects received an intra articular injection with liposomal bupivacaine, a total volume of 120 mL injected in the periarticular structures by the surgeon. Patients weighing 50-125 kg received 266mg of Liposomal Bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Nerve Block (PNB) | Active comparator | This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. Receives: Drug: Peripheral nerve blocks with Bupivacaine |
| Ropivacaine (PAI-R) | Active comparator | This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. Receives: Drug: Intra articular injection with Ropivacaine |
| Liposomal Bupivacaine (PAI-L) | Active comparator | This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. Receives: Drug: Intra articular injection with liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Pain Post-Operative Day (POD) 1 (Morning)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Measured: Post-Operative Day 1, approximately 6 am to 12:00 pm
Secondary outcomes (14)
Average Pain Post-Postanesthesia Care Unit (PACU)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Measured: Post-operative Day 0, approximately 12 pm to 12 am
Maximum Pain Post-PACU
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Measured: Post-operative Day 0, approximately 12 pm to 12 am
Average Pain POD 1 (24 Hours)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Measured: POD 1, approximately 12 am to 12 am next day
Maximum Pain POD 1 (24 Hours)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Measured: POD 1, approximately 12 am to 12 am next day
Average Pain POD 2 (24 Hours)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Measured: POD 2, approximately 12 am to 12 am next day
Maximum Pain POD 2 (24 Hours)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Measured: POD 2, approximately 12 am to 12 am next day
Preoperative Daily Opioid Use
Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.
Measured: baseline
Intraoperative Opioid Use
Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Measured: During the procedure, approximately 2 hours after start of the procedure
PACU Opioid Use
Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Measured: Approximately 2 hours after entry in PACU
POD 0 Post-PACU Opioid Use
Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Measured: POD 0, approximately 12 pm to 12 am
POD 1 Opioid Use
Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Measured: POD 1, approximately 12 am to 12 am next day
POD 2 Opioid Use
Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Measured: POD 2, approximately 12 am to 12 am next day
Hospital Length of Stay
The hospital length of stay was measured from the date of admittance until the date of discharge.
Measured: Approximately 3 days
Balance Testing on Operative Leg Using Unipedal Stance Time
In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.
Measured: baseline, approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra (Sandy) L. Kopp, M.D., Mayo Clinic
- Investigators
- Sandra Kopp, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223364
- Sponsor's protocol ID
- 14-002083
- Status last verified
- Aug 2017
- First submitted
- 29 Jul 2014
- Last updated
- 31 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586.
PubMed 28234636
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Trial Comparing Continuous Femoral and Single Injection Sciatic Peripheral Nerve Blocks vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel) on Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02223364
- Acronym / sponsor ID
- 14-002083
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 31 Aug 2017
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 find a better way to make patients comfortable after their knee surgery. The investigators compared three ways of providing pain relief, either by use of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the surgical joint area with one of two different medicines, either ropivacaine or liposomal bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic nerve areas would result in lower pain scores and opioid consumption than either of the two injections in the surgical joint area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peripheral Nerve Block (PNB) | Active comparator | Drug: Peripheral nerve blocks with BupivacaineThis group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine. |
| Ropivacaine (PAI-R) | Active comparator | Drug: Intra articular injection with RopivacaineThis group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
| Liposomal Bupivacaine (PAI-L) | Active comparator | Drug: Intra articular injection with liposomal bupivacaineThis group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- Patients presenting for unilateral primary total knee replacement.
- No focal neurologic deficit of the surgical lower extremity.
- Cognitively intact with the ability to sign informed consent
Key exclusion criteria (13 listed)
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
- Body mass index (BMI) > 40 kg/m2
- Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib
- Major systemic medical problems such as:
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 |
|---|---|---|
| Peripheral nerve blocks with BupivacaineAlso: Marcaine, SensorcaineSubjects received Bupivacaine 0.5% preoperatively, then Bupivacaine 0.2% upon post anesthesia care unit (PACU) arrival via femoral nerve block, then Bupivacaine 0.25% via single-injection sciatic nerve. | Drug | Peripheral Nerve Block (PNB) |
| Intra articular injection with RopivacaineAlso: NaropinSubjects received an intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Ropivacaine dose depended upon body weight: 50-74.9 kg: 200 mg, 75-99.9 kg: 300 mg, 100-125 kg: 400 mg. | Drug | Ropivacaine (PAI-R) |
| Intra articular injection with liposomal bupivacaineAlso: ExparelSubjects received an intra articular injection with liposomal bupivacaine, a total volume of 120 mL injected in the periarticular structures by the surgeon. Patients weighing 50-125 kg received 266mg of Liposomal Bupivacaine. | Drug | Liposomal Bupivacaine (PAI-L) |
Primary outcome
Maximum Pain Post-Operative Day (POD) 1 (Morning)
Time frame: Post-Operative Day 1, approximately 6 am to 12:00 pm
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
14 secondary outcomes
Average Pain Post-Postanesthesia Care Unit (PACU)
Time frame: Post-operative Day 0, approximately 12 pm to 12 am
Maximum Pain Post-PACU
Time frame: Post-operative Day 0, approximately 12 pm to 12 am
Average Pain POD 1 (24 Hours)
Time frame: POD 1, approximately 12 am to 12 am next day
Maximum Pain POD 1 (24 Hours)
Time frame: POD 1, approximately 12 am to 12 am next day
Average Pain POD 2 (24 Hours)
Time frame: POD 2, approximately 12 am to 12 am next day
Maximum Pain POD 2 (24 Hours)
Time frame: POD 2, approximately 12 am to 12 am next day
Preoperative Daily Opioid Use
Time frame: baseline
Intraoperative Opioid Use
Time frame: During the procedure, approximately 2 hours after start of the procedure
PACU Opioid Use
Time frame: Approximately 2 hours after entry in PACU
POD 0 Post-PACU Opioid Use
Time frame: POD 0, approximately 12 pm to 12 am
POD 1 Opioid Use
Time frame: POD 1, approximately 12 am to 12 am next day
POD 2 Opioid Use
Time frame: POD 2, approximately 12 am to 12 am next day
Hospital Length of Stay
Time frame: Approximately 3 days
Balance Testing on Operative Leg Using Unipedal Stance Time
Time frame: baseline, approximately 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28234636Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586.
- Individual participant dataSharing planned: No
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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.
Sandra Kopp, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peripheral nerve blocks with Bupivacaine, Intra articular injection with Ropivacaine and Intra articular injection with liposomal bupivacaine in people with Total Knee Arthroplasty, run by Mayo Clinic 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 31 Aug 2017. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Pain Post-Operative Day (POD) 1 (Morning) (time frame: Post-Operative Day 1, approximately 6 am to 12:00 pm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223364, which also lists 1 linked publication.
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 31 Aug 2017.