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

NCT ID: NCT06179628

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-09
• Study Completion Date: 2024-07-24

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.

Conditions

Knee Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low Concentration and Volume

0.15% bupivacaine 10 ml boluses for continuous adductor canal block

Group Type: ACTIVE_COMPARATOR

Low bolus concentration and volume

Intervention Type: DRUG

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

Standard Concentration and Volume

0.25% bupivacaine 20 ml boluses for continuous adductor canal block

Group Type: PLACEBO_COMPARATOR

Low bolus concentration and volume

Intervention Type: DRUG

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

Interventions

Low bolus concentration and volume

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

Intervention Type: DRUG

Other Intervention Names

Low concentration and volume of bupivacaine bolus

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Wirinaree Kampitak, MD

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chulalongkorn University

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 32843799 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26582853 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30124351 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40393775 (View on PubMed)

Other Identifiers

0675/66

Identifier Type: -

Identifier Source: org_study_id