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Postoperative PainNCT05727137

Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty

A study testing Single shot adductor canal block and Continuous adductor canal block in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare the analgesic efficacy of daily single-shot adductor canal block(ABC) versus continuous ACB after total knee arthroplasty (TKA). Read more about this study

Who is it for?
Ages 19 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Single shot adductor canal block and Continuous adductor canal block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSouth Korea
Study dates
21 Feb 2023to 8 Mar 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 19 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ASA classification I, II, III
  • Patients scheduled for unilateral knee arthroplasty

Who cannot join

  • Anesthesia other than spinal anesthesia
  • Chronic opioid use
  • Uncontrolled diabetes of HbA1c>7.5
  • Neuromuscular pathology of the ipsilateral leg
  • Second-look knee arthroplasty
  • Inability to communicate (e.g. dementia)
Show all 9Show fewer
  • Hypersensitivity to ropivacaine
  • BMI > 40
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Analgesic Efficacy of Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty

This study will compare the analgesic efficacy of daily single-shot adductor canal block(ABC) versus continuous ACB after total knee arthroplasty (TKA).

Read the detailed description

Patients 19-75 years old, of ASA classification I-III scheduled for unilateral TKA, will be enrolled and randomized into two groups, single-shot ACB group and continuous ACB group. In both groups, participants will be administered a single-shot ACB immediately after the end of the operation. The single-shot ACB group will receive two separate single-shot ACBs, on the first and second postoperative day. A nerve block catheter will be placed in patients in the continuous ACB group, which will be connected to a patient-controlled analgesia pump until the second postoperative day. The primary outcome of this study is the average NRS pain score at rest from the end of surgery to 2 days after surgery.

Being tested
Single shot adductor canal block, Continuous adductor canal block
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Single shot adductor canal blockProcedure or surgery

    Single shot adductor canal block on the the first and second postoperative day.

  • Continuous adductor canal blockProcedure or surgery

    A catheter will be placed in the adductor canal and connected to a continuous patient-controlled analgesia pump.

Study groups in NCT05727137
Study groupRoleWhat they receive
Single shot adductor canal blockExperimentalNot described
Receives: Procedure: Single shot adductor canal block
Continuous adductor canal blockActive comparatorNot described
Receives: Procedure: Continuous adductor canal block

What is being measured

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

  1. Average NRS pain score at rest

    average of numerical rating scale (0: no pain, 10: worst imaginable pain) pain scores from 8 time points during 48h (+4h, +8h, +12h from end of surgery, 6AM, 2PM, 10PM of postoperative day 1, and 6AM and 2PM of postoperative day 2)

    Measured: first 48h after end of surgery

Secondary outcomes (24)

  1. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +4h from end of surgery

    Measured: +4h from end of surgery

  2. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +4h from end of surgery

    Measured: +4h from end of surgery

  3. NRS pain score at rest at +8h from end of surgery

    Measured: +8h from end of surgery

  4. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +8h from end of surgery

    Measured: +8h from end of surgery

  5. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +12h from end of surgery

    Measured: +12h from end of surgery

  6. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +12h from end of surgery

    Measured: +12h from end of surgery

  7. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 1

    Measured: 6AM on postoperative day 1

  8. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 6AM on postoperative day 1

    Measured: 6AM on postoperative day 1

  9. NRS pain score at rest at 2PM on postoperative day 1

    Measured: 2PM on postoperative day 1

  10. NRS pain score during movement at 2PM on postoperative day 1

    Measured: 2PM on postoperative day 1

  11. NRS pain score at rest at 10PM on postoperative day 1

    Measured: 10PM on postoperative day 1

  12. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 10PM on postoperative day 1

    Measured: 10PM on postoperative day 1

  13. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 2

    Measured: 6AM on postoperative day 2

  14. NRS pain score during movement at 6AM on postoperative day 2

    Measured: 6AM on postoperative day 2

  15. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 2PM on postoperative day 2

    Measured: 2PM on postoperative day 2

  16. numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 2PM on postoperative day 2

    Measured: 2PM on postoperative day 2

  17. Posteoperative opioid administration in morphine equivalents

    Measured: from end of surgery to 48h after surgery

  18. Incidence of catheter tip dislocation

    The catheter tip is considered to be dislocated if the catheter tip is located outside the adductor canal

    Measured: at 2PM on postoperative day 1 and 2

  19. Incidence of extravasation from catheter insertion site

    Measured: at 2PM on postoperative day 1 and 2

  20. Incidence of sleep disturbance due to pain

    Measured: from end of surgery to postoperative day 2

  21. Incidence of numbness of anterior thigh area

    Measured: at 2PM on postoperative day 1 and 2

  22. Strengh of quadratus femoris muscle (unit: kgf)

    Measured: at 2PM on postoperative day 1 and 2

  23. Incidence of falls during hospital stay

    Measured: from end of surgery to 48h after surgery

  24. Postoperative range of motion of knee joint

    Measured: at 2PM on postoperative day 1 and 2

Timeline

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

  1. First posted14 Feb 2023
  2. Study start21 Feb 2023
  3. Primary completion27 Oct 2023
  4. Study completion8 Mar 2024

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
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05727137
Sponsor's protocol ID
H-2209-136-1362
Status last verified
Apr 2024
First submitted
25 Jan 2023
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kim H, Yoo S, Kwon S, Kim Y, Bae J, Kim YJ, Cho YJ, Kim JT, Lim YJ. Analgesic Efficacy of Repeated Daily Injections Versus Continuous Adductor Canal Block After Total Knee Arthroplasty: An Open-Label, Randomized Clinical Trial. Anesth Analg. 2026 Jan 1;142(1):132-139. doi: 10.1213/ANE.0000000000007427. Epub 2025 Feb 18.

    PubMed 39964911

Questions about this trial

What is this clinical trial studying?

A study testing Single shot adductor canal block and Continuous adductor canal block in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.

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 2 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: finished, as of the sponsor's last update on 12 Apr 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 South Korea. 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?

Average NRS pain score at rest (time frame: first 48h after end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05727137, which also lists 1 linked publication.

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 12 Apr 2024.

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