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Osteoarthritis, KneeNCT07876310

A Randomized Comparison of the Efficacy of the IPACK Block Versus the Popliteal Plexus Block for Posterior Knee Analgesia, in Patients Undergoing a Total Knee Arthroplasty and Receiving a Continuous Distal Femoral Triangle Block

A study testing Ultrasound-Guided iPACK Block, Ultrasound-Guided Popliteal Plexus Block and Ultrasound-Guided Continuous Femoral Triangle Block in people with Osteoarthritis, Knee and Postoperative Pain, run by Clinica Santa Maria.

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

Total knee arthroplasty (TKA) is commonly associated with significant postoperative pain, including pain arising from the posterior aspect of the knee. Regional anesthesia techniques are frequently used as part of a multimodal analgesic strategy to improve pain control, reduce opioid requirements, and facilitate early… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Osteoarthritis, Knee, Postoperative Pain
What is being tested?
Ultrasound-Guided iPACK Block, Ultrasound-Guided Popliteal Plexus Block and Ultrasound-Guided Continuous Femoral Triangle Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 30 May 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

  • Adults aged 18-85 years.
  • Scheduled for elective unilateral primary total knee arthroplasty for knee osteoarthritis.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Ability to understand and use the 0-10 Numeric Rating Scale (NRS) for pain assessment.
  • Ability to understand and use the intravenous patient-controlled analgesia (PCA) device.
  • Ability to complete the Quality of Recovery-15 (QoR-15) questionnaire.
  • Ability to provide written informed consent.

Who cannot join

  • Revision or bilateral total knee arthroplasty.
  • Patient refusal or inability to provide informed consent.
  • Contraindication to peripheral nerve block, including infection at the needle insertion site or clinically significant coagulation abnormalities.
  • Known allergy or contraindication to the local anesthetics or analgesic medications used in the study protocol.
  • Pre-existing clinically significant sensory or motor neurological deficit affecting the operative lower limb.
  • Chronic opioid use or opioid dependence that could interfere with postoperative opioid consumption assessment.
Show all 9Show fewer
  • Inability to understand or operate the PCA device.
  • Cognitive impairment or communication difficulty preventing reliable assessment of pain, motor function, or QoR-15.
  • Any medical condition that, in the investigator's judgment, would make participation unsafe or interfere with assessment of the study outcomes.

Trial locations and contacts

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

Diego E Fernandez Mujica, Physician Anesthesiologist contact

+56987755235

fernandezm.diego@gmail.com

America P Cereno, Physician Anesthesiologist contact

+56981618482

a.pilar.cp@gmail.com

About this study

Official title: iPACK Block Versus Popliteal Plexus Block for Posterior Analgesia After Primary Total Knee Arthroplasty in Patients Receiving a Continuous Femoral Triangle Block: A Double-Blind Randomized Clinical Trial

Total knee arthroplasty (TKA) is commonly associated with significant postoperative pain, including pain arising from the posterior aspect of the knee. Regional anesthesia techniques are frequently used as part of a multimodal analgesic strategy to improve pain control, reduce opioid requirements, and facilitate early functional recovery.

This prospective, randomized, double-blind, superiority clinical trial will compare the analgesic efficacy of the interspace between the popliteal artery and capsule of the posterior knee (iPACK) block with the popliteal plexus block in adult patients undergoing elective unilateral primary total knee arthroplasty. All participants will receive a continuous femoral triangle block and a standardized multimodal postoperative analgesic regimen.

Read more

Participants will be randomly assigned to receive either an ultrasound-guided iPACK block or an ultrasound-guided popliteal plexus block. The primary outcome will be cumulative intravenous morphine consumption delivered through a patient-controlled analgesia (PCA) device during the first 24 hours after surgery.

Secondary outcomes will include cumulative morphine consumption during the first 12 hours, posterior knee pain at rest and during movement, time to first PCA morphine administration, quality of recovery assessed with the QoR-15 questionnaire, distal motor function, early functional recovery, block performance time, postoperative adverse effects, and neurological symptoms.

The study hypothesis is that the popliteal plexus block will provide superior opioid-sparing analgesia compared with the iPACK block when both techniques are combined with a continuous femoral triangle block, while preserving distal motor function and maintaining an acceptable safety profile.

Read the detailed description

Total knee arthroplasty (TKA) is commonly associated with significant postoperative pain, including pain arising from the posterior aspect of the knee. Effective multimodal analgesia is important to facilitate early mobilization, functional recovery, participation in physical therapy, and patient satisfaction while minimizing opioid consumption and opioid-related adverse effects.

Motor-sparing regional anesthesia techniques are an important component of multimodal analgesia for TKA. The femoral triangle block provides analgesia primarily to the anterior and medial aspects of the knee while aiming to preserve quadriceps motor function. However, additional regional anesthesia techniques are often required to adequately treat pain originating from the posterior aspect of the knee.

The interspace between the popliteal artery and capsule of the posterior knee (iPACK) block is commonly used to provide posterior knee analgesia by targeting terminal articular sensory branches while minimizing blockade of the main tibial and common peroneal nerves. The popliteal plexus block (PPB) is an alternative motor-sparing regional anesthesia technique targeting the neural plexus contributing to the sensory innervation of the posterior knee.

Previous randomized studies suggest that the popliteal plexus block can provide effective posterior knee analgesia while preserving distal motor function. Direct comparison with the iPACK block has demonstrated non-inferior analgesia and shorter block performance time. Nevertheless, uncertainty remains regarding whether the popliteal plexus block provides superior opioid-sparing analgesia compared with the iPACK block when both techniques are incorporated into an otherwise standardized multimodal analgesic regimen.

This prospective, randomized, double-blind, superiority clinical trial will compare ultrasound-guided popliteal plexus block with ultrasound-guided iPACK block in adults undergoing elective unilateral primary total knee arthroplasty. All participants will receive a continuous femoral triangle block and a standardized multimodal postoperative analgesic regimen.

Participants will be randomly allocated to one of two parallel groups. Participants in the active comparator group will receive an ultrasound-guided iPACK block, whereas participants in the experimental group will receive an ultrasound-guided popliteal plexus block. Perioperative anesthetic management, continuous femoral triangle analgesia, postoperative multimodal analgesia, and intravenous patient-controlled analgesia (PCA) settings will otherwise be standardized between groups.

The primary outcome will be cumulative intravenous morphine consumption administered through the PCA device during the first 24 hours after surgery. The study is designed to test the hypothesis that the popliteal plexus block is superior to the iPACK block in reducing 24-hour postoperative morphine consumption.

Secondary opioid-related outcomes will include cumulative intravenous morphine consumption during the first 12 hours after surgery and the time from the end of surgery to the first successful intravenous morphine administration through the PCA device.

Posterior knee pain will be evaluated separately at rest and during movement using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Posterior knee pain will be assessed at 2, 4, 6, 12, and 24 hours postoperatively.

Quality of postoperative recovery will be evaluated using the 15-item Quality of Recovery questionnaire (QoR-15). The questionnaire will be administered preoperatively and 24 hours after surgery. The 24-hour QoR-15 score will be compared between groups, with the preoperative score used as a baseline measure of recovery status.

Distal motor function will be evaluated by assessing ankle dorsiflexion and plantar flexion strength using the Medical Research Council (MRC) muscle strength scale. Motor function will be assessed preoperatively and at 6 and 24 hours postoperatively to determine whether either posterior knee block results in clinically relevant distal motor impairment.

Early functional recovery will also be assessed during the first postoperative physical therapy evaluation within 24 hours after surgery. The ability to perform an active straight leg raise will be recorded as a binary outcome (Yes/No). The ability to stand and ambulate using the prescribed assistive device, such as a walker or crutches, will also be recorded as a binary outcome (Yes/No). When ambulation is not achieved, the principal reason will be documented when possible, including motor weakness, pain, dizziness or hypotension, nausea, or other causes.

The technical efficiency of the two posterior knee blocks will be evaluated by measuring block performance time. Performance time will be recorded in minutes and defined as the interval from initial placement of the ultrasound transducer for acquisition of the block image until withdrawal of the block needle following completion of local anesthetic injection.

Postoperative adverse effects will include nausea and vomiting, pruritus, and urinary retention. Procedure-related safety outcomes will include accidental vascular puncture, local anesthetic systemic toxicity, and new postoperative neurological symptoms.

Neurological symptoms potentially related to the regional anesthesia procedures, including numbness, paresthesia, dysesthesia, weakness, or other new sensory or motor deficits affecting the operated lower limb, will be assessed during the postoperative period. Participants will additionally undergo a standardized telephone follow-up approximately 7 days after surgery to identify persistent or newly reported neurological symptoms. Participants reporting clinically relevant persistent, progressive, or motor neurological deficits will be referred for further clinical evaluation according to institutional practice.

The study aims to determine whether the popliteal plexus block provides superior opioid-sparing analgesia compared with the iPACK block when both are used as adjuncts to a continuous femoral triangle block for primary total knee arthroplasty. In addition to analgesic efficacy, the study will evaluate posterior knee pain, quality of recovery, distal motor function, early functional recovery, technical efficiency, and the safety profile of both regional anesthesia techniques.

Being tested
Ultrasound-Guided iPACK Block, Ultrasound-Guided Popliteal Plexus Block, Ultrasound-Guided Continuous Femoral Triangle Block
Keywords
Total Knee Arthroplasty, Regional Anesthesia, iPACK Block, Popliteal Plexus Block, Femoral Triangle Block, Multimodal Analgesia, Opioid Consumption, Quality of Recovery, QoR-15, Postoperative Pain
Medical subject headings
Osteoarthritis, Knee, Pain, Postoperative

What participants receive

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

  • Ultrasound-Guided iPACK BlockProcedure or surgery

    An ultrasound-guided iPACK block will be performed by depositing 20 mL of 0.25% bupivacaine in the tissue plane between the popliteal artery and the posterior capsule of the knee to provide analgesia to the posterior aspect of the knee while minimizing blockade of the major motor branches of the sciatic nerve

  • Ultrasound-Guided Popliteal Plexus BlockProcedure or surgery

    An ultrasound-guided popliteal plexus block will be performed using 20 mL of 0.25% bupivacaine. The technique is intended to provide analgesia to the posterior aspect of the knee by targeting the neural plexus contributing to the sensory innervation of the posterior knee while minimizing clinically relevant distal motor blockade

  • Ultrasound-Guided Continuous Femoral Triangle BlockProcedure or surgery

    All participants will receive an ultrasound-guided continuous femoral triangle block. An initial bolus of 20 mL of 0.25% bupivacaine will be administered, followed by a continuous infusion of 0.1% bupivacaine at 5 mL/hour through a perineural catheter as part of the standardized postoperative analgesic regimen

Study groups in NCT07876310
Study groupRoleWhat they receive
iPACK BlockActive comparatorParticipants allocated to this group will receive an ultrasound-guided iPACK (interspace between the popliteal artery and capsule of the posterior knee) block using 20 mL of 0.25% bupivacaine. All participants will also receive a continuous femoral triangle block and standardized multimodal postoperative analgesia
Receives: Procedure: Ultrasound-Guided iPACK Block; Procedure: Ultrasound-Guided Continuous Femoral Triangle Block
Popliteal Plexus BlockExperimentalParticipants allocated to this group will receive an ultrasound-guided popliteal plexus block using 20 mL of 0.25% bupivacaine. All participants will also receive a continuous femoral triangle block and standardized multimodal postoperative analgesia
Receives: Procedure: Ultrasound-Guided Popliteal Plexus Block; Procedure: Ultrasound-Guided Continuous Femoral Triangle Block

What is being measured

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

  1. Cumulative Intravenous Morphine Equivalent Consumption During the First 24 Hours After Surgery.

    Total cumulative intravenous morphine consumption administered through a patient-controlled analgesia (PCA) device during the first 24 hours after primary total knee arthroplasty. The total amount of morphine delivered by the PCA device will be recorded for each participant and expressed in milligrams (mg).

    Measured: From the end of surgery to 24 hours postoperatively.

Secondary outcomes (16)
  1. Cumulative Intravenous Morphine Consumption During the First 12 Hours After Surgery

    Total cumulative intravenous morphine consumption administered through a patient-controlled analgesia (PCA) device during the first 12 hours after primary total knee arthroplasty. The total amount of morphine delivered by the PCA device will be recorded for each participant and expressed in milligrams (mg).

    Measured: From the end of surgery to 12 hours postoperatively.

  2. Posterior Knee Pain During Movement

    Pain specifically localized to the posterior aspect of the operated knee will be assessed during movement using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.

    Measured: 2, 4, 6, 12, and 24 hours postoperatively.

  3. Posterior Knee Pain at Rest

    Pain specifically localized to the posterior aspect of the operated knee will be assessed at rest using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.

    Measured: 2, 4, 6, 12, and 24 hours postoperatively.

  4. Time to First Patient-Controlled Analgesia Morphine Demand

    Time elapsed from the end of surgery until the first successful intravenous morphine administration through the patient-controlled analgesia (PCA) device.

    Measured: From the end of surgery to 24 hours postoperatively.

  5. Change in Quality of Recovery-15 (QoR-15) Score at 24 Hours

    Quality of postoperative recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The questionnaire will be administered preoperatively and 24 hours after surgery. The QoR-15 total score ranges from 0 to 150, with higher scores indicating better quality of recovery. Change from the preoperative baseline score to the 24-hour postoperative score will be compared between groups

    Measured: Preoperatively and 24 hours after surgery.

  6. Ankle Dorsiflexion Motor Strength

    Motor strength of ankle dorsiflexion will be assessed using the Medical Research Council (MRC) muscle strength scale, ranging from 0 to 5, where 0 represents no visible muscle contraction and 5 represents normal strength against full resistance.

    Measured: Preoperatively, and at 6 and 24 hours postoperatively.

  7. Ankle Plantar Flexion Motor Strength

    Ankle plantar flexion strength will be assessed using the Medical Research Council (MRC) muscle strength scale, ranging from 0 to 5, where 0 represents no visible muscle contraction and 5 represents normal strength against full resistance.

    Measured: Preoperatively, and at 6 and 24 hours postoperatively.

  8. Ability to Perform an Active Straight Leg Raise

    The ability to actively elevate the operated lower limb with the knee maintained in extension will be assessed as a binary outcome (Yes/No). A successful straight leg raise will be defined as the participant being able to lift the operated leg from the bed while maintaining knee extension, without physical assistance.

    Measured: During the first postoperative physical therapy assessment, within 24 hours after surgery.

  9. Ability to Ambulate With an Assistive Device

    The ability to ambulate using the prescribed assistive device, such as a walker or crutches, will be assessed as a binary outcome (Yes/No) during the first postoperative physical therapy session. Successful ambulation will be defined as the participant being able to stand and ambulate using the prescribed assistive device, with supervision or verbal guidance if required.

    Measured: During the first postoperative physical therapy session, within 24 hours after surgery.

  10. Performance Time of the Study Block

    The time required to perform the assigned posterior knee block (iPACK block or popliteal plexus block) will be recorded in minutes. Block performance time will be defined as the interval from initial placement of the ultrasound transducer for acquisition of the block image until withdrawal of the block needle following completion of local anesthetic injection.

    Measured: During performance of the study regional anesthesia procedure.

  11. Incidence of Postoperative Nausea and Vomiting

    Number and proportion of participants experiencing nausea and/or vomiting during the first 24 hours after surgery.

    Measured: Within 24 hours after surgery.

  12. Incidence of Postoperative Pruritus

    Number and proportion of participants experiencing pruritus during the first 24 hours after surgery.

    Measured: Within 24 hours after surgery

  13. Incidence of Postoperative Urinary Retention

    Number and proportion of participants developing urinary retention during the first 24 hours after surgery.

    Measured: Within 24 hours after surgery.

  14. Incidence of Accidental Vascular Puncture

    Number and proportion of participants in whom accidental vascular puncture occurs during performance of the study regional anesthesia procedure.

    Measured: During performance of the regional anesthesia procedure.

  15. Incidence of Local Anesthetic Systemic Toxicity

    Number and proportion of participants presenting signs or symptoms consistent with local anesthetic systemic toxicity following regional anesthesia.

    Measured: From performance of the regional anesthesia procedures to 24 hours postoperatively.

  16. Incidence of Postoperative Neurological Symptoms

    The number and proportion of participants presenting new neurological symptoms potentially related to the regional anesthesia procedures will be recorded. Symptoms of interest will include persistent numbness, paresthesia, dysesthesia, weakness, or other new sensory or motor deficits. Neurological symptoms will be assessed during the first 24 hours after surgery and reassessed by a standardized telephone follow-up approximately 7 days after surgery.

    Measured: From the regional anesthesia procedure through 7 days postoperatively.

Timeline

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

  1. First posted15 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion30 May 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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876310
Sponsor's protocol ID
192808-26
Status last verified
Oct 2026
First submitted
9 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request to the principal investigator. Requests will be evaluated based on scientific merit and will be subject to applicable institutional and ethical requirements.

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided iPACK Block, Ultrasound-Guided Popliteal Plexus Block and Ultrasound-Guided Continuous Femoral Triangle Block in people with Osteoarthritis, Knee and Postoperative Pain, run by Clinica Santa Maria.

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 7 inclusion and 9 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 15 Oct 2026. 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 Diego E Fernandez Mujica, Physician Anesthesiologist (+56987755235, fernandezm.diego@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Intravenous Morphine Equivalent Consumption During the First 24 Hours After Surgery. (time frame: From the end of surgery to 24 hours postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Oct 2026.

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