Knee ArthropathyNCT06179628
Low vs Standard Local Anesthetics Boluses for Continuous Adductor Canal Block in Total Knee Arthroplasty
A study testing Low bolus concentration and volume in people with Knee Arthropathy, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Low bolus concentration and volume
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- 9 Dec 2023to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Low bolus concentration and volume
- Keywords
- Adductor canal block, local infiltration analgesia, Postoperative pain management, Quadriceps strength, Total knee arthroplasty, Local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low bolus concentration and volumeDrug
Also called Low concentration and volume of bupivacaine bolus
Compare Low and Standard concentrations and volumes of bupivacaine boluses for continuous adductor block
| Study group | Role | What they receive |
|---|---|---|
| Low Concentration and Volume | Active comparator | 0.15% bupivacaine 10 ml boluses for continuous adductor canal block Receives: Drug: Low bolus concentration and volume |
| Standard Concentration and Volume | Placebo comparator | 0.25% bupivacaine 20 ml boluses for continuous adductor canal block Receives: Drug: Low bolus concentration and volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 12 hours after surgery
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: preoperative to day 7 after hospital discharge
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
Measured: preoperative - postoperative day 2
morphine consumption in milligrams
Patient's morphine consumption at postoperative day 0,1,2
Measured: 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)
Measured: postoperative day 0-2
The time to first rescue analgesia
the period from the CACB administration to the first IV morphine administration
Measured: postoperative day 0-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start9 Dec 2023
- Primary completion17 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wirinaree Kampitak, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179628
- Sponsor's protocol ID
- 0675/66
- Status last verified
- Aug 2024
- First submitted
- 26 Nov 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32843799Jaeger 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.
PubMed 26582853Tao 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.
PubMed 30124351Kampitak 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.
PubMed 40393775
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06179628
- Acronym / sponsor ID
- 0675/66
- Conditions
- Knee Arthropathy
- Keywords
- Adductor canal block, local infiltration analgesia, Postoperative pain management, Quadriceps strength, Total knee arthroplasty, Local anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 9 Dec 2023 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Concentration and Volume | Active comparator | Drug: Low bolus concentration and volume0.15% bupivacaine 10 ml boluses for continuous adductor canal block |
| Standard Concentration and Volume | Placebo comparator | Drug: Low bolus concentration and volume0.25% bupivacaine 20 ml boluses for continuous adductor canal block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low bolus concentration and volumeAlso: Low concentration and volume of bupivacaine bolusCompare Low and Standard concentrations and volumes of bupivacaine boluses for continuous adductor block | Drug | Low Concentration and Volume, Standard Concentration and Volume |
Primary outcome
Average knee pain score assessed by Numerical rating scale (NRS)
Time frame: 6 hours after surgery
Average postoperative pain score assessed by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)
Average knee pain score assessed by Numerical rating scale (NRS)
Time frame: 12 hours after surgery
Average postoperative pain score assessed by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)
8 secondary outcomes
The degree of active range of motion (ROM) of knee joint
Time frame: preoperative - postoperative day 2
Functional outcomes assessed by Five Times Sit to Stand Test (5XSST)
Time frame: preoperative - postoperative day 2
Functional outcomes assessed by Time Up and Go (TUG) test
Time frame: preoperative - postoperative day 2
Postoperative pain score assessed by Numerical rating scale (NRS)
Time frame: preoperative to day 7 after hospital discharge
Quadriceps strength assessed by maximum voluntary isometric contraction (MVIC) in Newton
Time frame: preoperative - postoperative day 2
morphine consumption in milligrams
Time frame: post0perative day 0-2
postoperative complications assessed by Likert scale
Time frame: postoperative day 0-2
The time to first rescue analgesia
Time frame: postoperative day 0-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Results publication: PubMed 32843799Chadha 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.
- Results publication: PubMed 26582853Jaeger 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.
- Results publication: PubMed 30124351Tao 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.
- Derived from this study: PubMed 40393775Kampitak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low bolus concentration and volume in people with Knee Arthropathy, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average knee pain score assessed by Numerical rating scale (NRS) (time frame: 6 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06179628, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.