Knee ArthropathyPhase 4NCT06653621
Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement
A Phase 4 study testing Bupivacaine liposome, Nerve block mode : adductor block and Bupivacaine in people with Knee Arthropathy and Knee Arthritis, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study was to investigate the effect of bupivacaine liposomes on postoperative pain in TKA ( total knee replacement ) patients.The main questions answered are: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Arthropathy, Knee Arthritis
- What is being tested?
- Bupivacaine liposome, Nerve block mode : adductor block and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2024to 31 Dec 2025
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASAI-ⅲ
- Receive a unilateral initial TKA
- Age 18-80 years old -
Who cannot join
- Bilateral TKA surgery
- TKA revision surgery
- Contraindications for nerve block and intraspinal anesthesia
- Allergies to local anesthetics
- Diabetic neuropathy
- Patients who are unable to cooperate with the evaluation
Show all 11Show fewer
- Chronic use of opioid analgesics
- BMI≥35kg/cm2
- Cases of lumbar anesthesia failure requiring general anesthesia surgery
- Cases of nerve block failure
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Lingli DENG
Wuhan, Hubei, 430030
lingli DENG, MD, +86 18707159290, 296890303@qq.com
wei mei, MD, +86 13006162508, 296890303@qq.com
About this study
Official title: Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement: a Prospective, Single-center, Simple Randomized, Active-controlled, Single-blind, 2x2 Factorial Design Clinical Study
The purpose of this study was to investigate the effect of bupivacaine liposomes on postoperative pain in TKA ( total knee replacement ) patients.The main questions answered are:
- Is bupivacaine liposomes superior to bupivacaine in femoral triangle block or adductor block in terms of 72 hours opioid consumption after knee replacement
- Which block method(Femoral triangle block or adductor block) combined with bupivacaine liposome was more effective in alleviating pain score and 72 hours opioid consumption after total knee surgery. investigators will investigate the effect of bupivacaine liposomes combined with bupivacaine and pure bupivacaine on pain after total knee arthroplasty using femoral triangle block or adductor block.
Read more
Participants will:
- Receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
- Undergo total knee replacement surgery under spinal anesthesia.
- Follow-up within 72 hours after surgery , opioid consumption, NRS score, PCA（Patient controlled analgesia，PCA） data, first postoperative remedial analgesia time, quadriceps muscle strength and complications were recorded
Read the detailed description
The patients received femoral triangle block plus iPACK(infiltration between popliteal artery and capsule of knee) block or adductor canal block plus iPACK block during induction .
The local anesthetic formulation was bupivacaine (0.75% bupivacaine hydrochloride 10ml+ normal saline 20ml) or bupivacaine liposome (0.75% bupivacaine hydrochloride 10ml+ bupivacaine liposome 20ml(266mg)).
- Conditions
- Knee Arthropathy, Knee Arthritis
- Being tested
- Bupivacaine liposome, Nerve block mode : adductor block, Bupivacaine, Nerve block mode: femoral triangle block
- Keywords
- Knee Arthropathy, liposome bupivacaine, femoral nerve block, adductor canal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine liposomeDrug
Also called L
Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
Nerve block mode : adductor blockProcedure or surgery
Also called A
Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance.
BupivacaineDrug
Also called B
Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
Nerve block mode: femoral triangle blockProcedure or surgery
Also called F
Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| adductor block+ Bupivacaine liposomes and bupivacaine mixture | Experimental | The patient underwent ultrasound-guided bupivacaine liposome mixture single adductor block during anesthesia induction room for analgesia after total knee arthroplasty . Receives: Drug: Bupivacaine liposome; Procedure: Nerve block mode : adductor block |
| adductor block+ bupivacaine | Active comparator | The patient underwent ultrasound-guided bupivacaine single adductor block during anesthesia induction room for analgesia after total knee arthroplasty Receives: Procedure: Nerve block mode : adductor block; Drug: Bupivacaine |
| femoral triangle block + Bupivacaine liposomes and bupivacaine mixture | Experimental | The patient underwent ultrasound-guided bupivacaine liposome mixture single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty . Receives: Drug: Bupivacaine liposome; Procedure: Nerve block mode: femoral triangle block |
| femoral triangle block + bupivacaine | Active comparator | The patient underwent ultrasound-guided bupivacaine single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty . Receives: Drug: Bupivacaine; Procedure: Nerve block mode: femoral triangle block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption 72 hours after surgery
This primary outcome entails tracking and assessing the total opioid consumption by participants following total knee replacement surgery. The evaluation includes quantifying the amount of opioids prescribed and consumed by participants for pain management post-surgery. Opioid medications administered will be converted to morphine equivalents based on established conversion ratios. By analyzing overall opioid consumption, the study aims to evaluate the efficacy of the interventions in managing postoperative pain.
Measured: this outcome will be monitored and recorded within 72 hours postoperatively
Secondary outcomes (4)
Pain intensity
Pain intensity will be assessed using the Numerical Rating Scale (NRS), a 0-10 scale where 0 represents no pain and 10 represents the worst imaginable pain
Measured: Pain intensity will be measured at 8 time points: 6 hours, 12 hours, 18 hours and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery
Time to First Rescue Analgesic
Time to first rescue analgesic will be recorded as the interval from the end of the surgery to the administration of the first dose of rescue analgesic medication postoperatively.
Measured: 72 hours after surgery
Total opioid dosage and PCA times
The evaluation includes quantifying the amount of opioids prescribed and consumed PCA times by participants for pain management post-surgery.
Measured: Total opioid dosage and PCA times were recorded at 8 time points: 6 hours, 12 hours, 18 hours and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery
Quadriceps muscle strength
The quadriceps muscle strength is measured with a hand-held dynamometer
Measured: 24.48,72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start5 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Huazhong University of Science and TechnologyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study utilizes a factorial interventional design, where participants undergoing total knee arthroplasty surgery will be allocated into four separate groups. Group one will receive liposomal bupivacaine plus bupivacaine as a regional anesthetic for adductor block, the group two will receive bupivacaine for adductor block; the group three will receive liposomal bupivacaine plus bupivacaine as a regional anesthetic for femoral nerve block ; Group four will receive bupivacaine as a regional anesthetic for femoral nerve block .Two types of interventions are involved, namely, choice of anesthesia mode (2 levels: adductor block, femoral triangle block) and anesthetic administration (2 levels: bupivacaine liposomes and bupivacaine mixture, bupivacaine).The study aims to compare the analgesic efficacy, duration of pain relief, opioid consumption, between the four groups .
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- wei mei, MD, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653621
- Sponsor's protocol ID
- TJ-IRB202409095
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chuan A, Lansdown A, Brick KL, Bourgeois AJG, Pencheva LB, Hue B, Goddard S, Lennon MJ, Walters A, Auyong D; Continuous Catheters in Adductor Canal versus Femoral Triangle (The CAFE study) investigators. Adductor canal versus femoral triangle anatomical locations for continuous catheter analgesia after total knee arthroplasty: a multicentre randomised controlled study. Br J Anaesth. 2019 Sep;123(3):360-367. doi: 10.1016/j.bja.2019.03.021. Epub 2019 May 2.
PubMed 31056239Song L, Li Y, Xu Z, Geng ZY, Wang DX. Comparison of the ultrasound-guided single-injection femoral triangle block versus adductor canal block for analgesia following total knee arthroplasty: a randomized, double-blind trial. J Anesth. 2020 Oct;34(5):702-711. doi: 10.1007/s00540-020-02813-8. Epub 2020 Jun 12.
PubMed 32533332
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement: a Prospective, Single-center, Simple Randomized, Active-controlled, Single-blind, 2x2 Factorial Design Clinical Study
- ClinicalTrials.gov ID
- NCT06653621
- Acronym / sponsor ID
- TJ-IRB202409095
- Conditions
- Knee Arthropathy, Knee Arthritis
- Keywords
- Knee Arthropathy, liposome bupivacaine, femoral nerve block, adductor canal block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Oct 2024 (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 purpose of this study was to investigate the effect of bupivacaine liposomes on postoperative pain in TKA ( total knee replacement ) patients.The main questions answered are:
- Is bupivacaine liposomes superior to bupivacaine in femoral triangle block or adductor block in terms of 72 hours opioid consumption after knee replacement
- Which block method(Femoral triangle block or adductor block) combined with bupivacaine liposome was more effective in alleviating pain score and 72 hours opioid consumption after total knee surgery. investigators will investigate the effect of bupivacaine liposomes combined with bupivacaine and pure bupivacaine on pain after total knee arthroplasty using femoral triangle block or adductor block.
Participants will:
- Receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
- Undergo total knee replacement surgery under spinal anesthesia.
- Follow-up within 72 hours after surgery , opioid consumption, NRS score, PCA（Patient controlled analgesia，PCA） data, first postoperative remedial analgesia time, quadriceps muscle strength and complications were recorded
Detailed description
The patients received femoral triangle block plus iPACK(infiltration between popliteal artery and capsule of knee) block or adductor canal block plus iPACK block during induction .
The local anesthetic formulation was bupivacaine (0.75% bupivacaine hydrochloride 10ml+ normal saline 20ml) or bupivacaine liposome (0.75% bupivacaine hydrochloride 10ml+ bupivacaine liposome 20ml(266mg)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This study utilizes a factorial interventional design, where participants undergoing total knee arthroplasty surgery will be allocated into four separate groups. Group one will receive liposomal bupivacaine plus bupivacaine as a regional anesthetic for adductor block, the group two will receive bupivacaine for adductor block; the group three will receive liposomal bupivacaine plus bupivacaine as a regional anesthetic for femoral nerve block ; Group four will receive bupivacaine as a regional anesthetic for femoral nerve block .Two types of interventions are involved, namely, choice of anesthesia mode (2 levels: adductor block, femoral triangle block) and anesthetic administration (2 levels: bupivacaine liposomes and bupivacaine mixture, bupivacaine).The study aims to compare the analgesic efficacy, duration of pain relief, opioid consumption, between the four groups .
| Arm | Type | Receives |
|---|---|---|
| adductor block+ Bupivacaine liposomes and bupivacaine mixture | Experimental | Drug: Bupivacaine liposome, Procedure: Nerve block mode : adductor blockThe patient underwent ultrasound-guided bupivacaine liposome mixture single adductor block during anesthesia induction room for analgesia after total knee arthroplasty . |
| adductor block+ bupivacaine | Active comparator | Procedure: Nerve block mode : adductor block, Drug: BupivacaineThe patient underwent ultrasound-guided bupivacaine single adductor block during anesthesia induction room for analgesia after total knee arthroplasty |
| femoral triangle block + Bupivacaine liposomes and bupivacaine mixture | Experimental | Drug: Bupivacaine liposome, Procedure: Nerve block mode: femoral triangle blockThe patient underwent ultrasound-guided bupivacaine liposome mixture single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty . |
| femoral triangle block + bupivacaine | Active comparator | Drug: Bupivacaine, Procedure: Nerve block mode: femoral triangle blockThe patient underwent ultrasound-guided bupivacaine single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ASAI-ⅲ
- Receive a unilateral initial TKA
- Age 18-80 years old -
Key exclusion criteria (11 listed)
- Bilateral TKA surgery
- TKA revision surgery
- Contraindications for nerve block and intraspinal anesthesia
- Allergies to local anesthetics
- Diabetic neuropathy
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 |
|---|---|---|
| Bupivacaine liposomeAlso: LSubjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance. | Drug | adductor block+ Bupivacaine liposomes and bupivacaine mixture, femoral triangle block + Bupivacaine liposomes and bupivacaine mixture |
| Nerve block mode : adductor blockAlso: ASubjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance. | Procedure or surgery | adductor block+ Bupivacaine liposomes and bupivacaine mixture, adductor block+ bupivacaine |
| BupivacaineAlso: BSubjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance. | Drug | adductor block+ bupivacaine, femoral triangle block + bupivacaine |
| Nerve block mode: femoral triangle blockAlso: FSubjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance. | Procedure or surgery | femoral triangle block + Bupivacaine liposomes and bupivacaine mixture, femoral triangle block + bupivacaine |
Primary outcome
Opioid consumption 72 hours after surgery
Time frame: this outcome will be monitored and recorded within 72 hours postoperatively
This primary outcome entails tracking and assessing the total opioid consumption by participants following total knee replacement surgery. The evaluation includes quantifying the amount of opioids prescribed and consumed by participants for pain management post-surgery. Opioid medications administered will be converted to morphine equivalents based on established conversion ratios. By analyzing overall opioid consumption, the study aims to evaluate the efficacy of the interventions in managing postoperative pain.
4 secondary outcomes
Pain intensity
Time frame: Pain intensity will be measured at 8 time points: 6 hours, 12 hours, 18 hours and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery
Time to First Rescue Analgesic
Time frame: 72 hours after surgery
Total opioid dosage and PCA times
Time frame: Total opioid dosage and PCA times were recorded at 8 time points: 6 hours, 12 hours, 18 hours and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery
Quadriceps muscle strength
Time frame: 24.48,72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 31056239Chuan A, Lansdown A, Brick KL, Bourgeois AJG, Pencheva LB, Hue B, Goddard S, Lennon MJ, Walters A, Auyong D; Continuous Catheters in Adductor Canal versus Femoral Triangle (The CAFE study) investigators. Adductor canal versus femoral triangle anatomical locations for continuous catheter analgesia after total knee arthroplasty: a multicentre randomised controlled study. Br J Anaesth. 2019 Sep;123(3):360-367. doi: 10.1016/j.bja.2019.03.021. Epub 2019 May 2.
- Background: PubMed 32533332Song L, Li Y, Xu Z, Geng ZY, Wang DX. Comparison of the ultrasound-guided single-injection femoral triangle block versus adductor canal block for analgesia following total knee arthroplasty: a randomized, double-blind trial. J Anesth. 2020 Oct;34(5):702-711. doi: 10.1007/s00540-020-02813-8. Epub 2020 Jun 12.
- 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.
wei mei, MD principal investigator
Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine liposome, Nerve block mode : adductor block and Bupivacaine in people with Knee Arthropathy and Knee Arthritis, run by Huazhong University of Science and Technology at 1 site in China.
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 11 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 24 Oct 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Llingli deng, postgraduate (+86 18707159290, 296890303@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption 72 hours after surgery (time frame: this outcome will be monitored and recorded within 72 hours postoperatively). 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 NCT06653621, which also lists 2 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 24 Oct 2024.