Pain, Postoperative
Conditions
Brief 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 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
Interventions
DRUGregional anesthesia and PAI
this is the block portion of the study
DRUGPAI
this is the no block portion of the study
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
patients will not know which group they are in
Intervention model description
patients will be randomized into 2 groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * Allergy or intolerance to trial medications * Planned admission to a postoperative rehabilitation facility * Planned general anesthesia * Receiving workers compensation or disability payments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively | at 2 weeks | pain score 0-10 10 being more pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | postop day 2 | 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 |
| Daily Step Count at 2 Weeks Postop | 2 weeks postop | step count throught fitbit |
| Oxford Knee Score | baseline | 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. |
| Sleep Quality Via Survey That Patients Completed Ranging From Very Good Sleep and Fairly Good Sleep | baseline % 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 baseline timepoint. |
| Sleep Quality Via App Surveys With Range of Very Good Sleep and Fairly Good Sleep | 7 days postop % of fairly good to very 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. |
| Sleep Quality Via App Surveys With Range of Very Good Sleep to Fairly Good Sleep | 14 days postop % 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrew Schneider, MD
Washington University School of Medicine
Participant flow
Pre-assignment details
patients are randomized once consented. patients have been withdrawn and not all patients are analyzed due to incomplete data . these patients are not patients that are just prescreened. they actually are enrolled and randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 40 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Age, Continuous | 65.1 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
None listed