Low Versus Standard Concentrations and Volumes Local Anesthetics Boluses for Continuous Adductor Canal Block Under Ultrasound-guidance in Total Knee Arthroplasty

Knee Arthropathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179628
• Other study ID #: 0675/66
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Chulalongkorn University
• Contact: Wanasrisant
• Phone: +66853599593
• Email: ttata.nw[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Total knee arthroplasty (TKA) is a commonly performed surgical procedure for patients with severe knee osteoarthritis. However, one of the challenges associated with total knee arthroplasty 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. The aim of this study is to investigate the efficacy of two different regimens of bupivacaine used in boluses for continuous adductor canal block under ultrasound-guidance in total knee arthroplasty at King Chulalongkorn Memorial Hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

Drug:
• Low and standard concentrations and volumes
Compare low and standard concentrations and volumes of bupivacaine boluses for continuous adductor block

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average knee pain score assessed by NRS	Average postoperative pain score assessed by NRS from 0-10	12 hours after surgery
Primary	Change in Quadriceps strength assessed by maximum voluntary isometric contraction (MVIC) in Newton	Compare the quadriceps strength in Newton by MVIC between preoperative period and postoperative day 1	preoperative - 12 hours after surgery
Secondary	patient satisfaction assessed by NRS	Evaluate patient satisfaction by NRS from 0-10 before discharge from the hospital and 7 days after hospital discharge	60 hours after surgery - 7 days after hospital discharge
Secondary	Length of hospital stay assessed by hours	Evaluate length of hospital stay (from admission to hospital discharge) by hours	60 hours after surgery
Secondary	Functional outcomes assessed by Knee Society Score (KSS), Five Times Sit to Stand Test (5XSST) , Time Up and Go (TUG)	Evaluate patient's functional outcomes by KSS, 5XSST, TUG tests at preoperative and postoperative day 0,1,2	preoperative - postoperative day 2
Secondary	Postoperative pain score assessed by NRS	Postoperative pain score at rest and on movement assessed by NRS from 0-10 at preoperative, 0,12,24,36,48,60 hours postoperatively, day 1-7 after hospital discharge	preoperative - day 7 after hospital discharge
Secondary	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
Secondary	morphine consumption in milligrams	Patient's morphine consumption at postoperative day 0,1,2	postperative day 0-2
Secondary	postoperative complications assessed by Likert scale	postoperative complications such as nausea/vomitting, sleep disturbance and fall assessed by Likert scale from 1-7	postperative day 0-2