ClinicalTrials.gg
CompletedNCT06179628Updated Aug 12, 2024

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

An interventional study of Low bolus concentration and volume in Knee Arthropathy, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.

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

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Knee Arthropathy

Keywords

  • Adductor canal block
  • local infiltration analgesia
  • Postoperative pain management
  • Quadriceps strength
  • Total knee arthroplasty
  • Local anesthesia
03

In context

Lead sponsor

Chulalongkorn University is the lead sponsor of 321 studies on the registry; 64 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • Active comparator
    Low Concentration and Volume

    0.15% bupivacaine 10 ml boluses for continuous adductor canal block

    Drug: Low bolus concentration and volume

  • Placebo comparator
    Standard Concentration and Volume

    0.25% bupivacaine 20 ml boluses for continuous adductor canal block

    Drug: Low bolus concentration and volume

Interventions

  • DrugLow bolus concentration and volume

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

    Also known as: Low concentration and volume of bupivacaine bolus

06

What researchers measure

Primary outcomes

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

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

    Time frame: 6 hours after surgery

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

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

    Time frame: 12 hours after surgery

Secondary outcomes

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

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

    Time frame: preoperative - postoperative day 2

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

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

    Time frame: preoperative - postoperative day 2

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

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

    Time frame: preoperative - postoperative day 2

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

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

    Time frame: preoperative to day 7 after hospital discharge

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

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

    Time frame: preoperative - postoperative day 2

  6. morphine consumption in milligrams

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

    Time frame: post0perative day 0-2

  7. postoperative complications assessed by Likert scale

    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)

    Time frame: postoperative day 0-2

  8. The time to first rescue analgesia

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

    Time frame: postoperative day 0-2

Other outcomes

  1. Length of hospital stay assessed by hours

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

    Time frame: postoperative day 2

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

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

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

07

Study locations

1 site
  • Chulalongkorn University
    Bangkok, 10310, Thailand
08

References and documents

Publications

  • Chadha M, Si S, Bhatt D, Krishnan S, Kumar R, Bansal A, Sharma AK. The Comparison of Two Different Volumes of 0.5% Ropivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block Onset and Duration of Analgesia for Upper Limb Surgery: A Randomized Controlled Study. Anesth Essays Res. 2020 Jan-Mar;14(1):87-91. doi: 10.4103/aer.AER_4_20. Epub 2020 Mar 16. PubMed 32843799 ↗
  • Jaeger P, Jenstrup MT, Lund J, Siersma V, Brondum V, Hilsted KL, Dahl JB. Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95. Br J Anaesth. 2015 Dec;115(6):920-6. doi: 10.1093/bja/aev362. PubMed 26582853 ↗
  • Tao Y, Zheng SQ, Xu T, Wang G, Wang Y, Wu AS, Yue Y. Median effective volume of ropivacaine 0.5% for ultrasound-guided adductor canal block. J Int Med Res. 2018 Oct;46(10):4207-4213. doi: 10.1177/0300060518791685. Epub 2018 Aug 20. PubMed 30124351 ↗
  • Kampitak W, Tanavalee A, Ngarmukos S, Wanasrisant N, Homsuwan W. Comparison of 10 mL 0.15% vs 20 mL 0.25% bupivacaine boluses for continuous adductor canal block in total knee arthroplasty: a randomized non-inferiority trial. Reg Anesth Pain Med. 2025 May 20:rapm-2025-106587. doi: 10.1136/rapm-2025-106587. Online ahead of print. PubMed 40393775 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06179628
Responsible party
Wirinaree Kampitak, MD (Clinical Associate Professor, Chulalongkorn University) — Principal investigator
First posted
Dec 22, 2023
Start date
Dec 9, 2023
Primary completion
Jul 17, 2024
Completion
Jul 24, 2024
Last update
Aug 12, 2024

Oversight

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

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion