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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06179628
Enrollment
140
Registered
2023-12-22
Start date
2023-12-09
Completion date
2024-07-24
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthropathy

Keywords

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

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.

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.

Interventions

DRUGLow bolus concentration and volume

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

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Average knee pain score assessed by Numerical rating scale (NRS)6 hours after surgeryAverage postoperative pain score assessed by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)

Secondary

MeasureTime frameDescription
The degree of active range of motion (ROM) of knee jointpreoperative - postoperative day 2Evaluate patient's functional outcomes by the degree of knee active ROM (measured by a goniometer) at preoperative and postoperative day 0,1,2
Functional outcomes assessed by Five Times Sit to Stand Test (5XSST)preoperative - postoperative day 2Evaluate patient's functional outcomes by 5XSST at preoperative and postoperative day 0,1,2
Functional outcomes assessed by Time Up and Go (TUG) testpreoperative - postoperative day 2Evaluate patient's functional outcomes by TUG tests at preoperative and postoperative day 0,1,2
Postoperative pain score assessed by Numerical rating scale (NRS)preoperative to day 7 after hospital dischargePostoperative pain score at rest and on movement assessed by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)
postoperative complications assessed by Likert scalepostoperative day 0-2postoperative 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)
The time to first rescue analgesiapostoperative day 0-2the period from the CACB administration to the first IV morphine administration
Quadriceps strength assessed by maximum voluntary isometric contraction (MVIC) in Newtonpreoperative - postoperative day 2Quadriceps strength assessed by MVIC in Newton at 90 degrees at preoperative and postoperative day 0,1,2
morphine consumption in milligramspost0perative day 0-2Patient's morphine consumption at postoperative day 0,1,2

Other

MeasureTime frameDescription
Length of hospital stay assessed by hourspostoperative day 2Evaluate length of hospital stay (from admission to hospital discharge) by hours
patient satisfaction assessed by Numerical rating scale (NRS)48 hours after surgery and 7 days after hospital dischargeEvaluate patient satisfaction by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026