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NCT Number: NCT06514365

Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery.

Total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. In turn, this is associated with more subsequent chronic pain.

There are multiple options and the tendency is to perform increasingly distal nerve blocks to minimize limb weakness and thus allow early rehabilitation. In 2012, in an oral communication, Sanjay Sinha described a new nerve block called iPACK ("Interspace between the Popliteal Artery and the Capsule of the posterior Knee"). There are few studies on the efficacy of such a blockade so far, but none comparing the groups saphene + sciatic blocks vs. saphene + iPACK blocks.

Therefore, this study aims to provide more information on the effectiveness this nerve blocks, in total knee replacement, in terms of analgesia and motor function.

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Key information

Conditions

Pain, Acute Acute Pain Anesthesia Arthritis Bites and Stings Chemically-Induced Disorders Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Poisoning Rheumatic Diseases Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location status: Recruiting

Location contact

Madalina Dinu

CONTACT

[email protected]

0034600349517

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons
  • Locoregional anesthesia
  • Age equal to or greater than 18 years
  • Consent to participate in the study

Exclusion criteria

  • Age under 18 years old
  • General anesthesia
  • Allergy to local anesthetics
  • Severe kidney failure (Cr ≥ 2mg / dL)
  • Chronic opioid use (over 3 months)
  • Chronic pregabalin / gabapentin use (more than 3 months)
  • Psychiatric illness that may interfere with the evaluation or follow-up

Treatment and study plan

IPACK block with Bupivacaine 0.25% with adrenaline

Drug

The iPACK in performed in the popliteal fossa about 1 finger breath above the patella, ecoguided. That aims to anesthetize the articular branches to the posterior aspect of the knee in the popliteal region.

Other names: Interspace between the Popliteal Artery and the Capsule of the posterior Knee

Primary outcomes

  1. Pain at rest

    Time frame: 6 hours after surgery

    Measured by the numerical visual scale at 6 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

  2. Pain at rest

    Time frame: 24 hours after surgery

    Measured by the numerical visual scale at 24 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

  3. Pain at rest

    Time frame: 48 hours after surgery

    Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

  4. Pain at movement

    Time frame: 6 hours after surgery

    Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

  5. Pain with movement

    Time frame: 24 hours after surgery

    Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

  6. Pain with movement

    Time frame: 48 hours after surgery

    Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

  7. Motor block

    Time frame: 6 hours after surgery

    Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).

  8. Motor block

    Time frame: 24 hours after surgery

    Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).

  9. Motor block

    Time frame: 48 hours after surgery

    Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).

Secondary outcomes

  1. Opioids dose

    Time frame: 6 hours after surgery

    Measured in milligrams of intravenous morphine hydrochloride daily.

  2. Opioids dose

    Time frame: 24 hours after surgery

    Measured in milligrams of intravenous morphine hydrochloride daily.

  3. Opioids dose

    Time frame: 48 hours after surgery

    Measured in milligrams of intravenous morphine hydrochloride daily.

  4. Discharge days

    Time frame: Days

    Time to discharge measured in days

  5. Patient satisfaction

    Time frame: 24 hours after surgery

    Patient satisfaction on a scale of 0 to 10, where 0 is minimum satisfaction and 10 is maximum satisfaction.

  6. Ambulation time

    Time frame: Up to 24 hours

    Time to ambulation (measured in hours) from discharge from URPA

Study contacts

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

Madalina Dinu, Mrs

CONTACT

[email protected]

0034600349517

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery. A Double Blind Randomized Clinical Trial.

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

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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