Arthroplasty, Replacement, KneeNCT05518513
Continuous Infusion and Intermittent Bolus Adductor Canal Block for Total Knee Arthroplasty
A study testing Bupivacain in people with Arthroplasty, Replacement, Knee and Adductor Canal Block, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The investigators believed the analgesic efficacy of adductor canal block on patients receiving total knee arthroplasty. However, the analgesic effects of different delivery regimens and duration of effects are variable. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Adductor Canal Block
- What is being tested?
- Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2022to 30 Sep 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults receiving unilateral total knee arthroplasty under spinal anesthesia
- American society of anesthesiologists 1-3
Who cannot join
- Could not cooperate
- Allergy to medicines used in the study
- Chronic pain
- Long term opioid use
- Neuromuscular disease
- Surgical complication: massive bleeding, postoperative ICU, unanticipated procedure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan
WEI-TENG WENG, bachelor, n112655@yahoo.com.tw
About this study
The investigators believed the analgesic efficacy of adductor canal block on patients receiving total knee arthroplasty. However, the analgesic effects of different delivery regimens and duration of effects are variable. The investigators hypothesize that using continuous infusion and shorter interval bolus of local anesthetics to perform adductor canal block will reduce pain scale and opioid consumption in patients receiving total knee arthroplasty compared with longer interval bolus of local anesthetics.
Read the detailed description
Sensory innervations contributing pain after total knee arthroplasty (TKA) include branches of femoral, obturator and sciatic nerves. Branches of femoral nerve contribute the most pain sensation in TKA including nerves to the vastus medialis, intermedius, and lateralis, medial and intermediate femoral cutaneous, and saphenous nerves. Smaller contribution of pain sensation from branches of fibular and tibial nerves, and posterior branch of obturator nerve. Multiple techniques of nerve block could anesthetize some or all of the sensory innervations, but analgesia with motor sparing is important for early recovery and rehabilitation after TKA. For both pain reduction and motor function, adductor canal block (ACB) combined with local infiltration analgesia is considered more feasible than other peripheral nerve blocks.
ACB could anesthetize nerves beyond in adductor canal. Anatomical studies revealed the extended spreading of local anesthetics (LA) beyond adductor canal when performing ACB, and caudal spreading could reach popliteal fossa through adductor hiatus. Cephalad spreading of LA in ACB is limited and rarely extending to femoral triangle even when injecting from proximal adductor canal, but the cephalad spreading also depends on the volume of injectants and using tourniquets.
In clinical studies, both ACB injection site and volume of injectants were investigated. Clinical trials and systematic reviews revealed the similar efficacy of analgesia when ACB injection at proximal and distal adductor canal, although the volume and pattern of injection (bolus or continuous) were variable. Regarding to the volume of injectants, 20ml injectant of local anesthetics would be adequate without prominent motor impairment compared with smaller volume.
Previous systematic reviews and meta-analysis have confirmed better analgesia with continuous infusion of ACB than single shot, but few studies explored the difference of intermittent bolus and continuous infusion. One clinical trial compared continuous infusion and intermittent bolus of ACB in patients receiving TKA, two other trials investigated the difference in healthy volunteers and patients receiving knee arthroscopy. All these three studies concluded no difference of analgesic efficacy. However, no consistent volume and frequency of injection was studied. Whether longer interval of intermittent bolus was the same with continuous infusion in analgesic efficacy is still need to be further verified.
- Being tested
- Bupivacain
- Keywords
- total knee arthroplasty, adductor canal block, nerve block, regional analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called Marcaine
adductor canal block with 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion | Experimental | adductor canal block with continuous infusion of 0.25% bupivacaine 3.5 ml per hour for 2 days postoperatively Receives: Drug: Bupivacain |
| 12hrs intermittent bolus | Active comparator | adductor canal block with intermittent bolus of 0.25% bupivacaine 21 ml every 12 hours for 2 days postoperatively Receives: Drug: Bupivacain |
| 6hrs intermittent bolus | Experimental | adductor canal block with intermittent bolus of 0.25% bupivacaine 21 ml every 6 hours for 2 days postoperatively Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated morphine consumption
Additional morphine prescription
Measured: In postoperative 48 hours
Secondary outcomes (5)
Numerical pain scale at rest
From no pain felt as 0 to the most pain felt as 10, measuring pain score at postoperative care unit, 3/9 pm on operative day, 9 am and 3/9 pm on postoperative day 1, 9 am and 3/9 pm on postoperative day 2
Measured: In postoperative 2 days
Numerical pain scale during knee flexion
From no pain felt as 0 to the most pain felt as 10, measuring pain score at postoperative care unit, 3/9 pm on operative day, 9 am and 3/9 pm on postoperative day 1, 9 am and 3/9 pm on postoperative day 2
Measured: In postoperative 2 days
Percentage of muscle power decrement
Extension strength of thigh at surgical side, measurement before surgery and postoperatively, access by dynameter as participants sit and perform surgical leg thigh extension, assessing at 9 am on postoperative day 1 and 2
Measured: In postoperative 2 days
Postoperative nausea and vomiting
Access if any sensation of nausea or episodes of vomiting
Measured: In postoperative 2 days
Event of falling down
Record the number of events of falling down
Measured: In postoperative 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Nov 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
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 Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Teng Weng, National Cheng-Kung University Hospital
- Investigators
- WEI-TENG WENG, MD, Principal investigator, Department of Anesthesiology, National Cheng Kung University Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518513
- Sponsor's protocol ID
- NCKUH-11109019
- Status last verified
- Apr 2024
- First submitted
- 21 Aug 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monahan AM, Sztain JF, Khatibi B, Furnish TJ, Jaeger P, Sessler DI, Mascha EJ, You J, Wen CH, Nakanote KA, Ilfeld BM. Continuous Adductor Canal Blocks: Does Varying Local Anesthetic Delivery Method (Automatic Repeated Bolus Doses Versus Continuous Basal Infusion) Influence Cutaneous Analgesia and Quadriceps Femoris Strength? A Randomized, Double-Masked, Controlled, Split-Body Volunteer Study. Anesth Analg. 2016 May;122(5):1681-8. doi: 10.1213/ANE.0000000000001182.
PubMed 26863502Thapa D, Ahuja V, Verma P, Gombar S, Gupta R, Dhiman D. Post-operative analgesia using intermittent vs. continuous adductor canal block technique: a randomized controlled trial. Acta Anaesthesiol Scand. 2016 Nov;60(10):1379-1385. doi: 10.1111/aas.12787. Epub 2016 Sep 4.
PubMed 27592690Jaeger P, Baggesgaard J, Sorensen JK, Ilfeld BM, Gottschau B, Graungaard B, Dahl JB, Odgaard A, Grevstad U. Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Blinded, Controlled Clinical Trial. Anesth Analg. 2018 Jun;126(6):2069-2077. doi: 10.1213/ANE.0000000000002747.
PubMed 29293181Jagannathan R, Niesen AD, D'Souza RS, Johnson RL. Intermittent bolus versus continuous infusion techniques for local anesthetic delivery in peripheral and truncal nerve analgesia: the current state of evidence. Reg Anesth Pain Med. 2019 Apr;44(4):447-451. doi: 10.1136/rapm-2018-100082. Epub 2019 Feb 3.
PubMed 30914472
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion and Intermittent Bolus Adductor Canal Block for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05518513
- Acronym / sponsor ID
- NCKUH-11109019
- Keywords
- total knee arthroplasty, adductor canal block, nerve block, regional analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 26 Aug 2022 (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.
The investigators believed the analgesic efficacy of adductor canal block on patients receiving total knee arthroplasty. However, the analgesic effects of different delivery regimens and duration of effects are variable. The investigators hypothesize that using continuous infusion and shorter interval bolus of local anesthetics to perform adductor canal block will reduce pain scale and opioid consumption in patients receiving total knee arthroplasty compared with longer interval bolus of local anesthetics.
Detailed description
Sensory innervations contributing pain after total knee arthroplasty (TKA) include branches of femoral, obturator and sciatic nerves. Branches of femoral nerve contribute the most pain sensation in TKA including nerves to the vastus medialis, intermedius, and lateralis, medial and intermediate femoral cutaneous, and saphenous nerves. Smaller contribution of pain sensation from branches of fibular and tibial nerves, and posterior branch of obturator nerve. Multiple techniques of nerve block could anesthetize some or all of the sensory innervations, but analgesia with motor sparing is important for early recovery and rehabilitation after TKA. For both pain reduction and motor function, adductor canal block (ACB) combined with local infiltration analgesia is considered more feasible than other peripheral nerve blocks.
ACB could anesthetize nerves beyond in adductor canal. Anatomical studies revealed the extended spreading of local anesthetics (LA) beyond adductor canal when performing ACB, and caudal spreading could reach popliteal fossa through adductor hiatus. Cephalad spreading of LA in ACB is limited and rarely extending to femoral triangle even when injecting from proximal adductor canal, but the cephalad spreading also depends on the volume of injectants and using tourniquets.
In clinical studies, both ACB injection site and volume of injectants were investigated. Clinical trials and systematic reviews revealed the similar efficacy of analgesia when ACB injection at proximal and distal adductor canal, although the volume and pattern of injection (bolus or continuous) were variable. Regarding to the volume of injectants, 20ml injectant of local anesthetics would be adequate without prominent motor impairment compared with smaller volume.
Previous systematic reviews and meta-analysis have confirmed better analgesia with continuous infusion of ACB than single shot, but few studies explored the difference of intermittent bolus and continuous infusion. One clinical trial compared continuous infusion and intermittent bolus of ACB in patients receiving TKA, two other trials investigated the difference in healthy volunteers and patients receiving knee arthroscopy. All these three studies concluded no difference of analgesic efficacy. However, no consistent volume and frequency of injection was studied. Whether longer interval of intermittent bolus was the same with continuous infusion in analgesic efficacy is still need to be further verified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion | Experimental | Drug: Bupivacainadductor canal block with continuous infusion of 0.25% bupivacaine 3.5 ml per hour for 2 days postoperatively |
| 12hrs intermittent bolus | Active comparator | Drug: Bupivacainadductor canal block with intermittent bolus of 0.25% bupivacaine 21 ml every 12 hours for 2 days postoperatively |
| 6hrs intermittent bolus | Experimental | Drug: Bupivacainadductor canal block with intermittent bolus of 0.25% bupivacaine 21 ml every 6 hours for 2 days postoperatively |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults receiving unilateral total knee arthroplasty under spinal anesthesia
- American society of anesthesiologists 1-3
Key exclusion criteria (6 listed)
- Could not cooperate
- Allergy to medicines used in the study
- Chronic pain
- Long term opioid use
- Neuromuscular disease
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 |
|---|---|---|
| BupivacainAlso: Marcaineadductor canal block with 0.25% bupivacaine | Drug | 12hrs intermittent bolus, 6hrs intermittent bolus, Continuous infusion |
Primary outcome
Accumulated morphine consumption
Time frame: In postoperative 48 hours
Additional morphine prescription
5 secondary outcomes
Numerical pain scale at rest
Time frame: In postoperative 2 days
Numerical pain scale during knee flexion
Time frame: In postoperative 2 days
Percentage of muscle power decrement
Time frame: In postoperative 2 days
Postoperative nausea and vomiting
Time frame: In postoperative 2 days
Event of falling down
Time frame: In postoperative 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Results publication: PubMed 26863502Monahan AM, Sztain JF, Khatibi B, Furnish TJ, Jaeger P, Sessler DI, Mascha EJ, You J, Wen CH, Nakanote KA, Ilfeld BM. Continuous Adductor Canal Blocks: Does Varying Local Anesthetic Delivery Method (Automatic Repeated Bolus Doses Versus Continuous Basal Infusion) Influence Cutaneous Analgesia and Quadriceps Femoris Strength? A Randomized, Double-Masked, Controlled, Split-Body Volunteer Study. Anesth Analg. 2016 May;122(5):1681-8. doi: 10.1213/ANE.0000000000001182.
- Results publication: PubMed 27592690Thapa D, Ahuja V, Verma P, Gombar S, Gupta R, Dhiman D. Post-operative analgesia using intermittent vs. continuous adductor canal block technique: a randomized controlled trial. Acta Anaesthesiol Scand. 2016 Nov;60(10):1379-1385. doi: 10.1111/aas.12787. Epub 2016 Sep 4.
- Results publication: PubMed 29293181Jaeger P, Baggesgaard J, Sorensen JK, Ilfeld BM, Gottschau B, Graungaard B, Dahl JB, Odgaard A, Grevstad U. Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Blinded, Controlled Clinical Trial. Anesth Analg. 2018 Jun;126(6):2069-2077. doi: 10.1213/ANE.0000000000002747.
- Results publication: PubMed 30914472Jagannathan R, Niesen AD, D'Souza RS, Johnson RL. Intermittent bolus versus continuous infusion techniques for local anesthetic delivery in peripheral and truncal nerve analgesia: the current state of evidence. Reg Anesth Pain Med. 2019 Apr;44(4):447-451. doi: 10.1136/rapm-2018-100082. Epub 2019 Feb 3.
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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.
WEI-TENG WENG, MD principal investigator
Department of Anesthesiology, National Cheng Kung University Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacain in people with Arthroplasty, Replacement, Knee and Adductor Canal Block, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 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 Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Teng Weng, MD (+886-6-2353535 ext. 5348, n100390@mail.hosp.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulated morphine consumption (time frame: In postoperative 48 hours). 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 NCT05518513, 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 5 Apr 2024.