Readiness to DischargePhase 4PAI vs FNBNCT01335542
Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
A Phase 4 study testing Peri-Articular Injection and Epidural Pathway (PCEA+FNB) in people with Readiness to Discharge, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Readiness to Discharge
- What is being tested?
- Peri-Articular Injection and Epidural Pathway (PCEA+FNB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2011
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis scheduled for primary bicompartmental total knee arthroplasty with a participating surgeon
- Age 18 to 85 years old
- Planned use of regional anesthesia
- Ability to follow study protocol
- Up to 15 degrees varus, up to 15 degrees flexion and up to 15 degrees valgus
Who cannot join
- Patients younger than 18 years old and older than 85
- Patients intending to receive general anesthesia
- Allergy or intolerance to one of the study medications
- Patients with an ASA of IV
- Patients with insulin-dependent diabetes
- Patients with hepatic (liver) failure
Show all 13Show fewer
- Patients with chronic renal (kidney) failure
- Chronic opioid use (taking opioids for longer than 3 months)
- Patients with any prior major ipsilateral open knee surgery.
- Patients with flexion contracture of knee > 15 degrees
- Patients with varus deformity > 15 degrees
- Patients with valgus deformity > 15 degrees
- Patients with a contraindication to use of epinephrine
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a peri-articular injection (injection of pain medication around the knee), pills for pain and a pain patch on the skin. The purpose of this research project is to find out if one of these ways to treat pain is better than the other. The investigators will look at this question in many ways, but the main way is how long it takes for you to be judged ready for discharge from the hospital.
- Conditions
- Readiness to Discharge
- Being tested
- Peri-Articular Injection, Epidural Pathway (PCEA+FNB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-Articular InjectionProcedure or surgery
Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
Epidural Pathway (PCEA+FNB)Procedure or surgery
Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
| Study group | Role | What they receive |
|---|---|---|
| Epidural Pathway (PCEA+FNB) | Active comparator | Not described Receives: Procedure: Epidural Pathway (PCEA+FNB) |
| Peri-Articular Injection | Active comparator | Not described Receives: Procedure: Peri-Articular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome is Time Until a Patient is "Ready for Discharge."
The primary outcome is time until a patient is "ready for discharge." Discharge criteria are:
- PCA (if present) has been discontinued
- Not experiencing moderate or severe nausea (within last 4 hours).
- Solid food diet
- Able to urinate (Foley catheter removed)
- Pain: NRS <4.
- Surgical wound dry
- No acute medical problems
- Physical Therapy Criteria
- Independently transfer from supine to sit, from sitting to standing
- Ambulate 40 ft. without assistance
- Extension range of motion (< 10 degrees)
Measured: Participants will be followed for the duration of their hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionSep 2011
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.
- Other trials for Readiness to DischargeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques T YaDeau, M.D., Ph.D., Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335542
- Sponsor's protocol ID
- 2012-056
- Acronym
- PAI vs FNB
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2011
- Last updated
- 14 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
- ClinicalTrials.gov ID
- NCT01335542
- Acronym / sponsor ID
- PAI vs FNB / 2012-056
- Conditions
- Readiness to Discharge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Posted 20 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a peri-articular injection (injection of pain medication around the knee), pills for pain and a pain patch on the skin. The purpose of this research project is to find out if one of these ways to treat pain is better than the other. The investigators will look at this question in many ways, but the main way is how long it takes for you to be judged ready for discharge from the hospital.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Pathway (PCEA+FNB) | Active comparator | Procedure: Epidural Pathway (PCEA+FNB) |
| Peri-Articular Injection | Active comparator | Procedure: Peri-Articular Injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with osteoarthritis scheduled for primary bicompartmental total knee arthroplasty with a participating surgeon
- Age 18 to 85 years old
- Planned use of regional anesthesia
- Ability to follow study protocol
- Up to 15 degrees varus, up to 15 degrees flexion and up to 15 degrees valgus
Key exclusion criteria (13 listed)
- Patients younger than 18 years old and older than 85
- Patients intending to receive general anesthesia
- Allergy or intolerance to one of the study medications
- Patients with an ASA of IV
- Patients with insulin-dependent diabetes
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 |
|---|---|---|
| Peri-Articular InjectionPre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN) | Procedure or surgery | Peri-Articular Injection |
| Epidural Pathway (PCEA+FNB)Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV | Procedure or surgery | Epidural Pathway (PCEA+FNB) |
Primary outcome
The Primary Outcome is Time Until a Patient is "Ready for Discharge."
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days
The primary outcome is time until a patient is "ready for discharge." Discharge criteria are: * PCA (if present) has been discontinued * Not experiencing moderate or severe nausea (within last 4 hours). * Solid food diet * Able to urinate (Foley catheter removed) * Pain: NRS <4. * Surgical wound dry * No acute medical problems * Physical Therapy Criteria * Independently transfer from supine to sit, from sitting to standing * Ambulate 40 ft. without assistance * Extension range of motion (< 10 degrees)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jacques T YaDeau, M.D., Ph.D. principal investigator
Hospital for Special Surgery, New York
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 Peri-Articular Injection and Epidural Pathway (PCEA+FNB) in people with Readiness to Discharge, run by Hospital for Special Surgery, New York 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 5 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 14 Apr 2022. 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 20 Apr 2016). 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?
The Primary Outcome is Time Until a Patient is "Ready for Discharge." (time frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 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 14 Apr 2022.