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Completed

NCT Number: NCT05727137

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).

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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)
  • Hypersensitivity to ropivacaine
  • BMI > 40
  • Pregnancy

Treatment and study plan

Single Shot Adductor Canal Block

Procedure

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

Continuous adductor canal block

Procedure

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

Primary outcomes

  1. Average NRS pain score at rest

    Time frame: first 48h after end of surgery

    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)

Secondary outcomes

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

    Time frame: +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

    Time frame: +4h from end of surgery

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

    Time frame: +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

    Time frame: +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

    Time frame: +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

    Time frame: +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

    Time frame: 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

    Time frame: 6AM on postoperative day 1

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

    Time frame: 2PM on postoperative day 1

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

    Time frame: 2PM on postoperative day 1

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

    Time frame: 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

    Time frame: 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

    Time frame: 6AM on postoperative day 2

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

    Time frame: 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

    Time frame: 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

    Time frame: 2PM on postoperative day 2

  17. Posteoperative opioid administration in morphine equivalents

    Time frame: from end of surgery to 48h after surgery

  18. Incidence of catheter tip dislocation

    Time frame: at 2PM on postoperative day 1 and 2

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

  19. Incidence of extravasation from catheter insertion site

    Time frame: at 2PM on postoperative day 1 and 2

  20. Incidence of sleep disturbance due to pain

    Time frame: from end of surgery to postoperative day 2

  21. Incidence of numbness of anterior thigh area

    Time frame: at 2PM on postoperative day 1 and 2

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

    Time frame: at 2PM on postoperative day 1 and 2

  23. Incidence of falls during hospital stay

    Time frame: from end of surgery to 48h after surgery

  24. Postoperative range of motion of knee joint

    Time frame: at 2PM on postoperative day 1 and 2

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 14, 2023
Registry last updated
Apr 12, 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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