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Nerve BlockNCT04808947

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

A study testing Local infiltration analgesia and Ultrasound-guided adductor canal block in people with Nerve Block and Neuromuscular Blockade, run by Women's College Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Nerve Block, Neuromuscular Blockade
What is being tested?
Local infiltration analgesia and Ultrasound-guided adductor canal block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Jan 2027to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Didem Bozak contact

416-323-6008

didem.bozak@wchospital.ca

About this study

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

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.

Read the 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.

Being tested
Local infiltration analgesia, Ultrasound-guided adductor canal block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local infiltration analgesiaProcedure or surgery

    Procedure: Local infiltration analgesia performed by surgeons.

  • Ultrasound-guided adductor canal blockProcedure or surgery

    Also called iPACK block

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

Study groups in NCT04808947
Study groupRoleWhat they receive
Local infiltration analgesiaExperimentalPatients 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.
Receives: Procedure: Local infiltration analgesia
Local infiltration analgesia + ACB-iPACK blockActive comparatorPatients 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
Receives: Procedure: Local infiltration analgesia; Procedure: Ultrasound-guided adductor canal block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain at rest

    Area under the curve

    Measured: over the first 24 hours

  2. 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.

    Measured: 24 hours postoperatively

Secondary outcomes (6)

  1. Mean opioid analgesic consumption

    Postoperative cumulative oral morphine equivalent consumption during the first 24 hours

    Measured: 24 hours postoperatively

  2. Time to first analgesic request

    Measured: Up to 48 hours following surgery

  3. Pain Assessment (VAS)

    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

    Measured: at 0, 6, 12, 18 and 24 hours

  4. Risk of opioid-related side effects

    nausea, vomiting, pruritus, sedation

    Measured: Up until one month following nerve block

  5. Block-related complications

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

    Measured: Up until one month following nerve block

  6. Satisfaction with pain management

    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

    Measured: at 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study startJan 2027 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, parallel group, triple blind (patient, assessor, anesthesiologist in the operating room)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04808947
Sponsor's protocol ID
LIA vs. LIA + ACB-iPACK block
Status last verified
Jul 2025
First submitted
8 Mar 2021
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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: 10.1213/ANE.0000000000003794.

    PubMed 30234517

Questions about this trial

What is this clinical trial studying?

A study testing Local infiltration analgesia and Ultrasound-guided adductor canal block in people with Nerve Block and Neuromuscular Blockade, run by Women's College Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Didem Bozak (416-323-6008, didem.bozak@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain at rest (time frame: over the first 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04808947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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