Clinical trial NCT06179628: Low vs Standard Local Anesthetics Boluses for Continuous Adductor Canal Block in Total Knee Arthroplasty
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Keywords: Adductor canal block
local infiltration analgesia
Postoperative pain management
Quadriceps strength
Total knee arthroplasty
Local anesthesia
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Average knee pain score assessed by Numerical rating scale (NRS)
timeFrame: 6 hours after surgery
measure: Average knee pain score assessed by Numerical rating scale (NRS)
timeFrame: 12 hours after surgery
Secondary outcomes:
measure: The degree of active range of motion (ROM) of knee joint
timeFrame: preoperative - postoperative day 2
measure: Functional outcomes assessed by Five Times Sit to Stand Test (5XSST)
timeFrame: preoperative - postoperative day 2
measure: Functional outcomes assessed by Time Up and Go (TUG) test
timeFrame: preoperative - postoperative day 2
measure: Postoperative pain score assessed by Numerical rating scale (NRS)
timeFrame: preoperative to day 7 after hospital discharge
measure: Quadriceps strength assessed by maximum voluntary isometric contraction (MVIC) in Newton
timeFrame: preoperative - postoperative day 2
measure: morphine consumption in milligrams
timeFrame: post0perative day 0-2
measure: postoperative complications assessed by Likert scale
timeFrame: postoperative day 0-2
measure: The time to first rescue analgesia
timeFrame: postoperative day 0-2
Other outcomes:
measure: Length of hospital stay assessed by hours
timeFrame: postoperative day 2
measure: patient satisfaction assessed by Numerical rating scale (NRS)
timeFrame: 48 hours after surgery and 7 days after hospital discharge
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.