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Completed

NCT Number: NCT06179628

Low vs Standard Local Anesthetics Boluses for Continuous Adductor Canal Block in Total Knee Arthroplasty

To investigate the efficacy of two different regimens of local anesthetic boluses for continuous adductor canal block under ultrasound-guidance in total knee arthroplasty at King Chulalongkorn Memorial Hospital.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn University

Bangkok, 10310, Thailand

About this study

Total knee arthroplasty (TKA) is a commonly performed surgical procedure for patients with severe knee osteoarthritis. However, one of the challenges associated with TKA is the significant postoperative pain experienced by patients, which can delay early mobilization and physical therapy. Uncontrolled pain worsens patient outcomes and healthcare costs as it can increase the risk of complications after surgery. Therefore, effective pain management is important for optimizing patient outcomes and promoting a smooth recovery process.Despite the absence of a standardized recommendation for the volume and concentration of bolus administration in continuous adductor canal block (CACB), many previous studies, have demonstrated the efficacy of a high-dose bolus followed by a low-concentration local anesthetic infusion for CACB. However, these trials exhibited differences in the doses and volumes of bolus injection. Therefore, the necessity of high concentration and volume bolus CACB in combination with comprehensive multimodal analgesia and LIA for postoperative pain management in TKA remains uncertain. The aim of this study is to investigate the efficacy of two different regimens of local anesthetic used in boluses for continuous adductor canal block under ultrasound-guidance in total knee arthroplasty at King Chulalongkorn Memorial Hospital.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients undergoing TKA aged more than 18 years
  • Patients with American Society of Anesthesiologists (ASA) class 1-3
  • Patients with body weight index (BMI) 18-40 kg/m2

Exclusion criteria

  • Patient refusal to participate
  • Patients with known allergic to medications used in the research protocol
  • Patients with contraindications to neuraxial or regional anesthesia, including existing neuropathy or neurological deficits involving the lower extremities, coagulopathy or bleeding diathesis and local skin infections
  • Patients with contraindications to NSAIDs such as history of coronary artery bypass graft surgery, congestive heart failure, stroke, gastrointestinal bleedings or ulceration, asthma, hepatic and renal disease, abnormal coagulation, or pregnancy
  • Patients with chronic opioid use (opioids have been used daily or almost daily for more than three months or sixty milligrams or more of morphine has been used daily for more than one month) or diagnosed with neuropathic pain
  • Patients that are unable to perform preoperative Quantitative sensory testing.

Treatment and study plan

Low bolus concentration and volume

Drug

Compare Low and Standard concentrations and volumes of bupivacaine boluses for continuous adductor block

Other names: Low concentration and volume of bupivacaine bolus

Primary outcomes

  1. Average knee pain score assessed by Numerical rating scale (NRS)

    Time frame: 6 hours after surgery

    Average postoperative pain score assessed by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)

  2. Average knee pain score assessed by Numerical rating scale (NRS)

    Time frame: 12 hours after surgery

    Average postoperative pain score assessed by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)

Secondary outcomes

  1. The degree of active range of motion (ROM) of knee joint

    Time frame: preoperative - postoperative day 2

    Evaluate patient's functional outcomes by the degree of knee active ROM (measured by a goniometer) at preoperative and postoperative day 0,1,2

  2. Functional outcomes assessed by Five Times Sit to Stand Test (5XSST)

    Time frame: preoperative - postoperative day 2

    Evaluate patient's functional outcomes by 5XSST at preoperative and postoperative day 0,1,2

  3. Functional outcomes assessed by Time Up and Go (TUG) test

    Time frame: preoperative - postoperative day 2

    Evaluate patient's functional outcomes by TUG tests at preoperative and postoperative day 0,1,2

  4. Postoperative pain score assessed by Numerical rating scale (NRS)

    Time frame: preoperative to day 7 after hospital discharge

    Postoperative pain score at rest and on movement assessed by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)

  5. Quadriceps strength assessed by maximum voluntary isometric contraction (MVIC) in Newton

    Time frame: preoperative - postoperative day 2

    Quadriceps strength assessed by MVIC in Newton at 90 degrees at preoperative and postoperative day 0,1,2

  6. morphine consumption in milligrams

    Time frame: post0perative day 0-2

    Patient's morphine consumption at postoperative day 0,1,2

  7. postoperative complications assessed by Likert scale

    Time frame: postoperative day 0-2

    postoperative complications such as nausea/vomitting, sleep disturbance and fall assessed by Likert scale from 1-7 (1 = strongly disagree/ extremely unlikely, 2 = disagree/ unlikely, 3 = slightly disagree/ slightly unlikely, 4 = either, 5 = slightly agree/ slightly likely, 6 = agree/ likely, 7 = strongly agree/ extremely likely)

  8. The time to first rescue analgesia

    Time frame: postoperative day 0-2

    the period from the CACB administration to the first IV morphine administration

Other outcomes

  1. Length of hospital stay assessed by hours

    Time frame: postoperative day 2

    Evaluate length of hospital stay (from admission to hospital discharge) by hours

  2. patient satisfaction assessed by Numerical rating scale (NRS)

    Time frame: 48 hours after surgery and 7 days after hospital discharge

    Evaluate patient satisfaction by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Low Versus Standard Concentrations and Volumes Local Anesthetics Boluses for Continuous Adductor Canal Block Under Ultrasound-guidance in Total Knee Arthroplasty: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2023
Registry last updated
Aug 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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