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

NCT06179628 | Completed

• 1 other identifier: 0675/66
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthropathy

Keywords

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

Outcome Measures

Primary Outcomes (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)

  6 hours after surgery

• 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)

  12 hours after surgery

Secondary Outcomes (8)

• The degree of active range of motion (ROM) of knee joint

  preoperative - postoperative day 2

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

  preoperative - postoperative day 2

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

  preoperative - postoperative day 2

• Postoperative pain score assessed by Numerical rating scale (NRS)

  preoperative to day 7 after hospital discharge

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

  preoperative - postoperative day 2

Other Outcomes (2)

• Length of hospital stay assessed by hours

  postoperative day 2

• patient satisfaction assessed by Numerical rating scale (NRS)

  48 hours after surgery and 7 days after hospital discharge

Study Arms (2)

Low Concentration and Volume

ACTIVE COMPARATOR

0.15% bupivacaine 10 ml boluses for continuous adductor canal block

Drug: Low bolus concentration and volume

Standard Concentration and Volume

PLACEBO COMPARATOR

0.25% bupivacaine 20 ml boluses for continuous adductor canal block

Drug: Low bolus concentration and volume

Interventions

Low bolus concentration and volume DRUG

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

Also known as: Low concentration and volume of bupivacaine bolus

Low Concentration and Volume; Standard Concentration and Volume

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Bangkok, 10310, Thailand

Location

Related Publications (4)

• 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.

  PMID: 32843799 RESULT

• 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.

  PMID: 26582853 RESULT

• 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.

  PMID: 30124351 RESULT

• 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.

  PMID: 40393775 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 22, 2023
• Study Start: December 9, 2023
• Primary Completion: July 17, 2024
• Study Completion: July 24, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)