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

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthropathy
• Intervention / Treatment: Drug: Low bolus concentration and volume

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10310
    • Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low Concentration and Volume; 0.15% bupivacaine 10 ml boluses for continuous adductor canal block	Drug: Low bolus concentration and volume; Compare Low and Standard concentrations and volumes of bupivacaine boluses for continuous adductor block; Other Names: Low concentration and volume of bupivacaine bolus
Placebo Comparator: Standard Concentration and Volume; 0.25% bupivacaine 20 ml boluses for continuous adductor canal block	Drug: Low bolus concentration and volume; Compare Low and Standard concentrations and volumes of bupivacaine boluses for continuous adductor block; Other Names: Low concentration and volume of bupivacaine bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	preoperative - postoperative day 2
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	preoperative - postoperative day 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	preoperative - postoperative day 2
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	preoperative - postoperative day 2
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)	preoperative to day 7 after hospital discharge
morphine consumption in milligrams	Patient's morphine consumption at postoperative day 0,1,2	post0perative day 0-2
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)	postoperative day 0-2
The time to first rescue analgesia	the period from the CACB administration to the first IV morphine administration	postoperative day 0-2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay assessed by hours	Evaluate length of hospital stay (from admission to hospital discharge) by hours	postoperative day 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)	48 hours after surgery and 7 days after hospital discharge

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2023
• Primary Completion (Actual): July 17, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Local anesthesia; Postoperative pain management; local infiltration analgesia; Quadriceps strength; Adductor canal block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 0675/66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No