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
DRUGPAI
this is the no block portion of the study
DRUGregional anesthesia and PAI
this is the 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 |
|---|---|---|
| daily opioid consumption | daily up to 2 weeks postop | opioid medications survey |
| daily resting Visual Analog Scale (VAS) score | daily up to 2 weeks postop | Pain score survey 0-10, 10 being more pain |
| daily step count | daily up to 2 weeks postop | step count throught fitbit |
| length of stay | postop day 1 | in hospital stay |
| complications | 14 days postop | Number of participants with complications such as revision, infection, etc |
| knee range of motion | daily through app and knee brace up to 2 weeks postop | range of motion daily through app exercises |
| Oxford knee score | weekly up to 2 weeks postop | oxford knee survey through app, 0-48 scale 0 being min and 48 being max |
| sleep quality | daily up to 2 weeks postop | sleep quality through app surveys and fitbit data |
Countries
United States
Outcome results
None listed