Adductor Canal BlockNCT06525493
Comparison of Combination of Proximal ACB and iPACK With Large-Volume Distal ACB for Early Mobilization After TKR
A study testing Regional Anesthesia in people with Adductor Canal Block and Postoperative Pain, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adductor Canal Block, Postoperative Pain, Regional Anesthesia
- What is being tested?
- Regional Anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 50 - 80 years who underwent total knee replacement surgery
Who cannot join
- Systemic allergy, anaphylactic reaction, and occurrence of cardiac arrest
- Intraoperative fracture
- Change to general anesthesia
- Patient who decides to withdraw from the study.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, Indonesia
Jakarta Pusat, DKI Jakarta
About this study
Official 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
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
- Being tested
- Regional Anesthesia
- Keywords
- Total Knee Replacement, Adductor Canal Block, Postoperative Pain, Regional Anesthesia, Postoperative Mobilization, TUG Test
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional AnesthesiaProcedure or surgery
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%
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Procedure: Regional Anesthesia |
| Group B | Experimental | 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 Receives: Procedure: Regional Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The test is conducted specifically on the first day after the surgery, known as Postoperative Day 1 (POD 1)
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
Measured: The NRS assessments are conducted at 6 hours, 12 hours, and 24 hours after the surgery
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
Measured: The measurement is taken over the entire 24-hour period following the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adductor Canal BlockStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pryambodho Pryambodho, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525493
- Sponsor's protocol ID
- 585/UN2.F1/ETIK/PPM.00.02/2023
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06525493
- Acronym / sponsor ID
- 585/UN2.F1/ETIK/PPM.00.02/2023
- Keywords
- Total Knee Replacement, Adductor Canal Block, Postoperative Pain, Regional Anesthesia, Postoperative Mobilization, TUG Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Regional AnesthesiaPatients 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. |
| Group B | Experimental | Procedure: Regional AnesthesiaThis 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 50 - 80 years who underwent total knee replacement surgery
Key exclusion criteria (4 listed)
- Systemic allergy, anaphylactic reaction, and occurrence of cardiac arrest
- Intraoperative fracture
- Change to general anesthesia
- Patient who decides to withdraw from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional AnesthesiaThe 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% | Procedure or surgery | Group A, Group B |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional Anesthesia in people with Adductor Canal Block and Postoperative Pain, run by Universitas Indonesia at 1 site in Indonesia.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. 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 29 Jul 2024.