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Not yet recruiting NCT04808947

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

No phase Interventional Nerve Block Neuromuscular Blockade

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local infiltration analgesia, Ultrasound-guided adductor canal block.
Who it may be relevant to
Registry conditions: Nerve Block, Neuromuscular Blockade. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Local infiltration analgesia
    Procedure: Local infiltration analgesia performed by surgeons.
  • Procedure Ultrasound-guided adductor canal block
    Procedure: Ultrasound-guided adductor canal and iPACK blocks performed by anesthesiologists preoperatively.

Primary outcome measures

  • Postoperative pain at rest [Time frame: over the first 24 hours]
  • Quality of recovery (QoR-15) [Time frame: 24 hours postoperatively]
Secondary outcome measures (6)
  • Mean opioid analgesic consumption [Time frame: 24 hours postoperatively]
  • Time to first analgesic request [Time frame: Up to 48 hours following surgery]
  • Pain Assessment (VAS) [Time frame: at 0, 6, 12, 18 and 24 hours]
  • Risk of opioid-related side effects [Time frame: Up until one month following nerve block]
  • Block-related complications [Time frame: Up until one month following nerve block]
  • Satisfaction with pain management [Time frame: at 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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: PMID 30234517

Identifiers

NCT: NCT04808947 · LIA vs. LIA + ACB-iPACK block

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗