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Completed

NCT Number: NCT06525493

Comparison of Combination of Proximal ACB and iPACK With Large-Volume Distal ACB for Early Mobilization After TKR

Large-volume distal ACB is not superior to combination of proximal ACB and iPACK in facilitating early mobilization after TKR. Block performing time of distal ACB was significantly shorter compared to the combination of proximal ACB and iPACK

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

About this study

Adductor Canal Block (ACB) and Infiltration between Popliteal Artery and Capsule of Knee (iPACK) are popular block methods for analgesia after Total Knee Replacement (TKR), covering both anterior and posterior knee. Adductor canal serves as a passageway, local anesthetic injected here will spread both to proximal and distal to posterior. Study was a single-blinded, randomized controlled trial between June 2023 and January 2024. Large-volume distal ACB is not superior to combination of proximal ACB and iPACK in facilitating early mobilization after TKR. Block performing time of distal ACB was significantly shorter compared to the combination of proximal ACB and iPACK

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 50 - 80 years who underwent total knee replacement surgery

Exclusion criteria

  • Systemic allergy, anaphylactic reaction, and occurrence of cardiac arrest
  • Intraoperative fracture
  • Change to general anesthesia
  • Patient who decides to withdraw from the study.

Treatment and study plan

Regional Anesthesia

Procedure

The interventions are three different regional anesthesia techniques: Proximal Adductor Canal Block (ACB), iPACK (Interspace between the Popliteal Artery and the Capsule of the Posterior Knee), and Large-Volume Distal Adductor Canal Block (Large ACB distal). all three interventions were administered using ropivacaine 0.2%. However, there were differences in the volumes injected for each regional anesthesia technique. Proximal ACB: 15 mL of ropivacaine 0.2%. iPACK: 20 mL of ropivacaine 0.2%. Large ACB distal: 35 mL of ropivacaine 0.2%

Primary outcomes

  1. Timed Up and Go test on Postoperative Day 1 (POD 1)

    Time frame: The test is conducted specifically on the first day after the surgery, known as Postoperative Day 1 (POD 1)

    The Timed Up and Go (TUG) test is a functional mobility assessment used to evaluate a person's ability to stand up from a chair, walk a short distance, turn around, return to the chair, and sit down again. It assesses balance, gait, and functional mobility, which are crucial aspects of postoperative recovery.

  2. Numeric Rating Scale

    Time frame: The NRS assessments are conducted at 6 hours, 12 hours, and 24 hours after the surgery

    The NRS is a commonly used tool to assess pain intensity. Patients are typically asked to rate their pain on a numerical scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain

  3. Total 24 hours morphine consumption

    Time frame: The measurement is taken over the entire 24-hour period following the surgery

    This measures the total amount of morphine consumed by patients within the first 24 hours after surgery. It reflects the effectiveness of pain management strategies and the need for opioid analgesia

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison of Combination of Proximal Adductor Canal Block and Infiltration Between Popliteal Artery and Capsule of Knee With Large-Volume Distal Adductor Canal Block in Facilitating Early Mobilization After Total Knee Replacement

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Jul 29, 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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