Block and Periarticular Injection Study

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06410612
• Other study ID #: 202311211
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 4, 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 and functional outcomes in the early postoperative period following primary total knee arthroplasty.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• regional anesthesia and PAI
this is the block portion of the study
• PAI
this is the no block portion of the study

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Creve Coeur	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Visual Analog Scale (VAS) pain score for 2 weeks postoperatively	pain score 0-10 10 being more pain	at 2 weeks
Secondary	daily opioid consumption	opioid medications survey	daily up to 2 weeks postop
Secondary	daily resting Visual Analog Scale (VAS) score	Pain score survey 0-10, 10 being more pain	daily up to 2 weeks postop
Secondary	daily step count	step count throught fitbit	daily up to 2 weeks postop
Secondary	length of stay	in hospital stay	postop day 1
Secondary	complications	Number of participants with complications such as revision, infection, etc	14 days postop
Secondary	knee range of motion	range of motion daily through app exercises	daily through app and knee brace up to 2 weeks postop
Secondary	Oxford knee score	oxford knee survey through app, 0-48 scale 0 being min and 48 being max	weekly up to 2 weeks postop
Secondary	sleep quality	sleep quality through app surveys and fitbit data	daily up to 2 weeks postop