Pain, PostoperativePhase 4NCT06410612
Block and Periarticular Injection Study
A Phase 4 study testing regional anesthesia and PAI and PAI in people with Pain, Postoperative, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of the study is to compare two types of perioperative analgesic modalities, adductor canal block plus interspace between popliteal artery and capsule of the knee (IPACK) block and periarticular injection versus periarticular injection alone, to determine their relative efficacies with regard to pain relief… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- regional anesthesia and PAI and PAI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 12 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planning to undergo Unilateral primary total knee arthroplasty.
- 18 and up
- Willing to sign informed consent
- Willing to return for all follow-up visits
- Smartphone or tablet device capable of running the FocusMotion platform
Who cannot join
- BMI > 45
- Preexisting functionally limiting neurologic disorders
- Hepatic or renal insufficiency
- History of unprovoked venous thromboembolism
- Inability to complete baseline functional testing
- Chronic opioid or gabapentin and pregabalin use (chronic defined as use >5 days per week prior to the surgical procedure)
Show all 10Show fewer
- Allergy or intolerance to trial medications
- Planned admission to a postoperative rehabilitation facility
- Planned general anesthesia
- Receiving workers compensation or disability payments
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
Creve Coeur, Missouri, 63110
About this study
Official title: The Effect of Regional Anesthesia and Periarticular Injection and Versus Periarticular Injection Alone on Early Recovery After Total Knee Arthroplasty: A Prospective Randomized Trial
The purpose of the study is to compare two types of perioperative analgesic modalities, adductor canal block plus interspace between popliteal artery and capsule of the knee (IPACK) block and periarticular injection versus periarticular injection alone, to determine their relative efficacies with regard to pain relief and functional outcomes in the early postoperative period following primary total knee arthroplasty.
Read the detailed description
The widespread adoption of multimodal analgesia in contemporary total knee arthroplasty (TKA) has led to improvements in perioperative pain control, expedited recovery times, and shorter hospital stays1-3. Periarticular injections (PAIs), adductor canal blocks (ACBs), and interspace between popliteal artery and capsule of the knee (IPACK) blocks are commonly utilized as part of contemporary multimodal analgesia protocols, but their relative efficacies in improving early recovery after TKA has yet to be definitively elucidated4. There are a few known potential drawbacks of ACBs and IPACKs including surgical delay due to administration timing, increased costs, and small risks associated with a regional block. Both regional anesthesia and PAI have been found to be effective alone in improving pain and opioid consumption, but there is limited data on whether there is an additive benefit of providing both treatments for patients undergoing primary TKA. Therefore, the purpose of our study is to compare the efficacy of regional anesthesia and PAI vs. PAI alone for pain management and functional recovery in the early postoperative period following TKA.
Design Prospective randomized trial
Treatment Groups All ACBs will be administered as a single shot preoperatively in the holding area on the day of surgery by the regional anesthesia team and PAIs will be administered intraoperatively by the treating orthopaedic surgeon.
Group 1: regional anesthesia (ACB + IPACK) and PAI Group 2: PAI alone
- Conditions
- Pain, Postoperative
- Being tested
- regional anesthesia and PAI, PAI
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anesthesia and PAIDrug
Also called adductor canal block, periarticular injection
this is the block portion of the study
PAIDrug
Also called Periarticular injections
this is the no block portion of the study
| Study group | Role | What they receive |
|---|---|---|
| Block and Periarticular injection | Active comparator | regional anesthesia (Adductor canal block +IPACK) and Periarticular injection Receives: Drug: regional anesthesia and PAI; Drug: PAI |
| Periarticular injectin alone | Active comparator | Periarticular injection alone Receives: Drug: PAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively
pain score 0-10 10 being more pain
Measured: at 2 weeks
Secondary outcomes (8)
Opioid Use
opioid medications survey Opioids calculated MMEs (morphine milligram equivalents) milligrams of opioids correlates with the morphine equivalents.
Morphine equivalents are standard units used to compare the analgesic potency of different opioids to a reference dose of oral morphine. They calculate total daily, safe, and effective doses
Measured: postop day 2
Daily Step Count at 2 Weeks Postop
step count throught fitbit
Measured: 2 weeks postop
Oxford Knee Score
oxford knee survey through app, 0-48 scale 0 being min and 48 being max score assesses pain and function of the knee
Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention.
Score 20 to 29 May indicate moderate to severe knee arthritis.
Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment.
Measured: baseline
Sleep Quality Via Survey That Patients Completed Ranging From Very Good Sleep and Fairly Good Sleep
sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the baseline timepoint.
Measured: baseline % of very good sleep and fairly good sleep
Oxford Knee Score
oxford knee survey through app, 0-48 scale 0 being min and 48 being max assesses pain and function of the knee
Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention.
Score 20 to 29 May indicate moderate to severe knee arthritis.
Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment.
Measured: 7 days postop
Oxford Knee Score
oxford knee survey through app, 0-48 scale 0 being min and 48 being max assesses pain and function of the knee
Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention.
Score 20 to 29 May indicate moderate to severe knee arthritis.
Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment.
Measured: 14 days postop
Sleep Quality Via App Surveys With Range of Very Good Sleep and Fairly Good Sleep
sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the 7 day timepoint.
Measured: 7 days postop % of fairly good to very good sleep
Sleep Quality Via App Surveys With Range of Very Good Sleep to Fairly Good Sleep
sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the 14 day timepoint.
Measured: 14 days postop % of very good sleep to fairly good sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start4 Mar 2024
- Primary completion12 May 2025
- Study completion12 May 2025
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 Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomized into 2 groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Schneider, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410612
- Sponsor's protocol ID
- 202311211
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2024
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regional Anesthesia and Periarticular Injection and Versus Periarticular Injection Alone on Early Recovery After Total Knee Arthroplasty: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06410612
- Acronym / sponsor ID
- 202311211
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Posted 20 Apr 2026
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 the study is to compare two types of perioperative analgesic modalities, adductor canal block plus interspace between popliteal artery and capsule of the knee (IPACK) block and periarticular injection versus periarticular injection alone, to determine their relative efficacies with regard to pain relief and functional outcomes in the early postoperative period following primary total knee arthroplasty.
Detailed description
The widespread adoption of multimodal analgesia in contemporary total knee arthroplasty (TKA) has led to improvements in perioperative pain control, expedited recovery times, and shorter hospital stays1-3. Periarticular injections (PAIs), adductor canal blocks (ACBs), and interspace between popliteal artery and capsule of the knee (IPACK) blocks are commonly utilized as part of contemporary multimodal analgesia protocols, but their relative efficacies in improving early recovery after TKA has yet to be definitively elucidated4. There are a few known potential drawbacks of ACBs and IPACKs including surgical delay due to administration timing, increased costs, and small risks associated with a regional block. Both regional anesthesia and PAI have been found to be effective alone in improving pain and opioid consumption, but there is limited data on whether there is an additive benefit of providing both treatments for patients undergoing primary TKA. Therefore, the purpose of our study is to compare the efficacy of regional anesthesia and PAI vs. PAI alone for pain management and functional recovery in the early postoperative period following TKA.
Design Prospective randomized trial
Treatment Groups All ACBs will be administered as a single shot preoperatively in the holding area on the day of surgery by the regional anesthesia team and PAIs will be administered intraoperatively by the treating orthopaedic surgeon.
Group 1: regional anesthesia (ACB + IPACK) and PAI Group 2: PAI alone
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- patients will be randomized into 2 groups.
| Arm | Type | Receives |
|---|---|---|
| Block and Periarticular injection | Active comparator | Drug: regional anesthesia and PAI, Drug: PAIregional anesthesia (Adductor canal block +IPACK) and Periarticular injection |
| Periarticular injectin alone | Active comparator | Drug: PAIPeriarticular injection alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Planning to undergo Unilateral primary total knee arthroplasty.
- 18 and up
- Willing to sign informed consent
- Willing to return for all follow-up visits
- Smartphone or tablet device capable of running the FocusMotion platform
Key exclusion criteria (10 listed)
- BMI > 45
- Preexisting functionally limiting neurologic disorders
- Hepatic or renal insufficiency
- History of unprovoked venous thromboembolism
- Inability to complete baseline functional testing
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 |
|---|---|---|
| regional anesthesia and PAIAlso: adductor canal block, periarticular injectionthis is the block portion of the study | Drug | Block and Periarticular injection |
| PAIAlso: Periarticular injectionsthis is the no block portion of the study | Drug | Block and Periarticular injection, Periarticular injectin alone |
Primary outcome
Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively
Time frame: at 2 weeks
pain score 0-10 10 being more pain
8 secondary outcomes
Opioid Use
Time frame: postop day 2
Daily Step Count at 2 Weeks Postop
Time frame: 2 weeks postop
Oxford Knee Score
Time frame: baseline
Sleep Quality Via Survey That Patients Completed Ranging From Very Good Sleep and Fairly Good Sleep
Time frame: baseline % of very good sleep and fairly good sleep
Oxford Knee Score
Time frame: 7 days postop
Oxford Knee Score
Time frame: 14 days postop
Sleep Quality Via App Surveys With Range of Very Good Sleep and Fairly Good Sleep
Time frame: 7 days postop % of fairly good to very good sleep
Sleep Quality Via App Surveys With Range of Very Good Sleep to Fairly Good Sleep
Time frame: 14 days postop % of very good sleep to fairly good sleep
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Andrew Schneider, MD principal investigator
Washington University School of Medicine
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 regional anesthesia and PAI and PAI in people with Pain, Postoperative, run by Washington University School of Medicine 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 10 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 20 Apr 2026. 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 2026). 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?
Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively (time frame: at 2 weeks). 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 20 Apr 2026.