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NCT Number: NCT04808947

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

LIA is the mainstay of postoperative analgesia in patients having knee arthroplasty. Performed by surgeons, LIA provides effective postoperative pain relief and reduces opioid requirements. Similar analgesic benefits have also been attributed to adductor canal and iPACK blocks, which partially block sensory innervation to the knee and its posterior capsule. Performed by anesthesiologist preoperatively, these blocks have also been incorporated into the care standard in numerous centers. However, it is not clear whether adding the adductor canal and iPACK blocks yields any incremental analgesic benefits. The investigators aimed to evaluate the benefits of adding adductor canal and iPACK blocks to LIA in patients having total knee arthroplasty.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Local Infiltration Analgesia

Procedure

Procedure: Local infiltration analgesia performed by surgeons.

ultrasound-guided Adductor Canal Block

Procedure

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

Other names: iPACK block

Primary outcomes

  1. Postoperative pain at rest

    Time frame: over the first 24 hours

    Area under the curve

  2. Quality of recovery (QoR-15)

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

  1. Mean opioid analgesic consumption

    Time frame: 24 hours postoperatively

    Postoperative cumulative oral morphine equivalent consumption during the first 24 hours

  2. Time to first analgesic request

    Time frame: Up to 48 hours following surgery

  3. Pain Assessment (VAS)

    Time frame: at 0, 6, 12, 18 and 24 hours

    Visual Analogue Scale(VAS) - Pain:Overall pain assessed at rest and on movement A continuous scale comprised of a 100mm (10cm) horizontal line, anchored by 2 verbal descriptions No Pain to Worst Pain

  4. Risk of opioid-related side effects

    Time frame: Up until one month following nerve block

    nausea, vomiting, pruritus, sedation

  5. Block-related complications

    Time frame: Up until one month following nerve block

    vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block

  6. Satisfaction with pain management

    Time frame: at 24 hours

    A Patient Diary will be completed to assess overall satisfaction with analgesic technique 10 cm scale with "not satisfied at all" and "very satisfied" at either end

Study contacts

Contact information is provided by the study sponsor or research team.

Didem Bozak

CONTACT

[email protected]

416-323-6008

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Official study title

The Ideal Analgesic Technique for Total Knee Arthroplasty: A Randomized Comparison Between Local Infiltration Analgesia Alone or Combined With Adductor Canal and iPACK Blocks

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Mar 22, 2021
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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