LIA vs. LIA + ACB-iPACK Block for Total Knee Arthroplasty

NCT04808947 | Not Yet Recruiting

• 1 other identifier: LIA vs. LIA + ACB-iPACK block
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

LIA is the mainstay of postoperative analgesia in patients having knee arthroplasty. The combination of ACB-iPACK blocks has also been proposed as an effective analgesic modality for total knee arthroplasty. However, whether combining these two modalities yields any important incremental analgesic benefit remains unclear. The investigators hypothesized that the addition of ACB and iPACK blocks to LIA will yield clinically important analgesic benefits compared to LIA alone in patients having total knee arthroplasty.

Conditions

Nerve Block; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (2)

• Postoperative pain at rest

  Area under the curve

  over the first 24 hours

• Quality of recovery (QoR-15)

  Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome. QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions.

  24 hours postoperatively

Secondary Outcomes (6)

• Mean opioid analgesic consumption

  24 hours postoperatively

• Time to first analgesic request

  Up to 48 hours following surgery

• Pain Assessment (VAS)

  at 0, 6, 12, 18 and 24 hours

• Risk of opioid-related side effects

  Up until one month following nerve block

• Block-related complications

  Up until one month following nerve block

Study Arms (2)

Local infiltration analgesia

EXPERIMENTAL

Patients in this group will receive LIA intraoperatively, as per institutional standard. The injected solution will be comprised of 100cc Ropiv 2%, + Ketorolac 30 mg + Epinephrine 25 ug.

Procedure: Local infiltration analgesia

Local infiltration analgesia + ACB-iPACK block

ACTIVE COMPARATOR

Patients in this group will receive LIA intraoperatively, as per institutional standard. The injected solution will be comprised of 100cc Ropiv 2%, + Ketorolac 30 mg + Epinephrine 25 ug. Patients in this group will also receive preoperative nerve blocks under ultrasound guidance. These will include: 1. Adductor canal block with 0.5% Ropivacaine w/epi 20 mL 2. iPack block with 0.25% Ropivacaine w/epi 10 mL

Procedure: Local infiltration analgesia; Procedure: Ultrasound-guided adductor canal block

Interventions

Local infiltration analgesia PROCEDURE

Procedure: Local infiltration analgesia performed by surgeons.

Local infiltration analgesia; Local infiltration analgesia + ACB-iPACK block

Ultrasound-guided adductor canal block PROCEDURE

Procedure: Ultrasound-guided adductor canal and iPACK blocks performed by anesthesiologists preoperatively.

Also known as: iPACK block

Local infiltration analgesia + ACB-iPACK block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA classification I-III
• BMI \< 35 kg/m2
• Having elective unilateral total knee arthroplasty

You may not qualify if:

• Bilateral knee surgery.
• Pre-existing neurological deficit or peripheral neuropathy in the lower the lower limbs
• Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases
• Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma)
• Contraindication to regional anesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest)
• Patient refusal
• Chronic pain disorder
• Chronic opioid use (≥30 mg oxycodone / day)
• Contraindication (or allergy) to a component of multi-modal analgesia protocol
• Allergy to amide local anesthetics used in nerve blocks
• Contraindications to spinal anesthesia
• Significant psychiatric disorder that would preclude objective study assessment
• Pregnancy
• Inability to provide informed consent

Sponsors & Collaborators

• Women's College Hospital: lead

Related Publications (1)

• Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.

  PMID: 30234517 BACKGROUND

Study Officials

• Richard Brull, MD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didem Bozak

CONTACT

416-323-6008; didem.bozak@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel group, triple blind (patient, assessor, anesthesiologist in the operating room)

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 22, 2021
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-07