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CompletedNCT06525493Updated Jul 29, 2024

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

An interventional study of Regional Anesthesia in Adductor Canal Block, Postoperative Pain and Regional Anesthesia, sponsored by Indonesia University. Completed at 1 site in Indonesia. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jun 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Adductor Canal Block
  • Postoperative Pain
  • Regional Anesthesia

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Keywords

  • Total Knee Replacement
  • Adductor Canal Block
  • Postoperative Pain
  • Regional Anesthesia
  • Postoperative Mobilization
  • TUG Test
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 30 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Group A

    Patients receive the large-volume distal adductor canal block (ACB). In this technique, a linear transducer is placed on the medial aspect, approximately one fourth of the distal thigh to identify the Adductor Hiatus, and the injection is performed in-plane near that point using ropivacaine.

    Procedure: Regional Anesthesia

  • Experimental
    Group B

    This arm involves a combination of two regional anesthesia techniques: proximal adductor canal block (ACB) and iPACK. In proximal ACB, the transducer is placed in the middle of the thigh, and the injection is performed in-plane approximately 1-2 cm distal from a specific point. Meanwhile, in iPACK, the curvilinear transducer is positioned on the posteromedial aspect of the distal thigh, and the injection is performed between the popliteal artery and the femur

    Procedure: Regional Anesthesia

Interventions

  • ProcedureRegional Anesthesia

    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%

06

What researchers measure

Primary outcomes

  1. Timed Up and Go test on 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.

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

  2. Numeric Rating Scale

    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

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

  3. Total 24 hours morphine consumption

    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

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

07

Study locations

1 site
  • Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, Indonesia
    Jakarta Pusat, DKI Jakarta, Indonesia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06525493
Lead sponsor
Indonesia University
Responsible party
Pryambodho Pryambodho (dr, Indonesia University) — Principal investigator
First posted
Jul 29, 2024
Start date
Jun 1, 2023
Primary completion
Dec 1, 2023
Completion
Jan 1, 2024
Last update
Jul 29, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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