Infiltration Between the Popliteal Artery and the Capsule of the Knee (iPACK) With Local Infiltration of Analgesia (LIA) and Adductor Canal Block (ACB) Improves Postoperative Pain in Total Knee Arthroplasty: A Randomized Controlled Trial

"REB20-1633"

Total knee arthroplasty is an effective surgical intervention for patients with chronic osteoarthritis commonly performed worldwide. Postoperative pain management has been a key focus in patient care for this procedure. Poorly controlled pain following total knee arthroplasty is associated with decreased ambulation, increased length of hospital stay, increased complications (particularly related to significant opioid use), and overall suboptimal patient recovery. Appropriate postoperative pain management utilizing motor sparing peripheral nerve blocks and periarticular injections has been shown to provide faster, more optimized patient recovery and reduced hospital length of stay in patients undergoing total knee arthroplasty. Adductor canal block (ACB) is a well-studied peripheral nerve block performed for analgesia following total knee arthroplasty. ACB is an effective component of multimodal analgesia providing improved pain control to the peripatellar and intra-articular aspect of the knee joint while largely preserving the strength of the quadriceps muscles1. In addition, perioperative local infiltration analgesia (LIA) performed by the orthopaedic surgical team is a common practice that has been shown to improve short-term postoperative pain relief and reduce total systemic opioid consumption during hospital stay2 for total knee arthroplasty. The Infiltration between the Popliteal Artery and Capsule of the Knee (iPACK) block is a newly described regional anesthesia technique for postoperative analgesia in total knee arthroplasty, performed under ultrasound guidance. It targets the articular branches of the tibial, common peroneal, and obturator nerves in the popliteal region, and aims to provide analgesia to the posterior aspect of the knee joint without compromising lower extremity motor function following total knee arthroplasty. This study aims to determine whether the IPACK block provides additional analgesia (in combination with ACB + LIA) for total knee arthroplasty surgeries. The study will examine how much additional analgesia IPACK provides in the context of an already-optimized regional anesthesia pathway for total knee arthroplasty, which uses ACB + LIA, both modalities that have reasonable existing evidence.

2022-10-30

2024-05-30

2024-05-30

Recruiting

Early phase I

120

Inclusion Criteria: * Patients scheduled for elective unilateral TKA * Planned for regional anesthesia for the procedure * Age \>=18 Exclusion criteria: * Contraindications to regional anesthesia or peripheral nerve blocks * Allergy to local anesthetics or any of the study medications * Severe hepatic or renal insufficiency * Chronic opioid consumption * Patient with difficulty comprehending visual analogue scale pain scores * Pre-existing lower extremity neurologic abnormalities * Patients classified as American Society of Anesthesiologists score 3 or 4 * Language/communication barrier

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A will receive perioperative ACB, LIA, and sham IPACK block. Group B will receive perioperative ACB, LIA, and real IPACK block.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "The study personnel, including research team, anesthesiologists, surgeons, physiotherapists, recovery room and ward nurses, as well as patients will be blinded to the group allocation. Anesthesia assistants not involved in study data collection or patient care will prepare the sham or real local anesthetic injectate solution for iPACK block. Syringes will be prepared immediately after randomization and before block placement and provided to the blinded anesthesiologist.\n\nThe statistician who run randomization would only know study IDs and stay blinded to patients' treatment arms.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-05-10