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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:
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:
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)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 . |
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| adductor block+ bupivacaine | Active Comparator | The patient underwent ultrasound-guided bupivacaine single adductor block during anesthesia induction room for analgesia after total knee arthroplasty |
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| 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 . |
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| 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine liposome | Drug | Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | this outcome will be monitored and recorded within 72 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
Chronic use of opioid analgesics
BMI≥35kg/cm2
Cases of lumbar anesthesia failure requiring general anesthesia surgery
Cases of nerve block failure
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Llingli deng, postgraduate | Contact | +86 18707159290 | 296890303@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| wei mei, MD | Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lingli DENG | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31056239 | Background | 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. | |
| 32533332 |
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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 .
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Double (Participant, Outcomes Assessor) . Given the distinct visual appearance of the liposomal bupivacaine (milky white) and bupivacaine (transparent), a double-blind study design is not feasible. Consequently, this study employs a single-blind approach where neither participants nor outcome assessors will be aware of treatment allocation. Healthcare providers administering the study drug will be aware of the treatment group assignment. Rigorous procedures will be implemented to minimize potential bias, including standardized outcome assessment tools, blinded data entry, and independent data analysis.
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| Nerve block mode : adductor block | Procedure | Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance. |
|
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| Bupivacaine | Drug | Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance. |
|
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| Nerve block mode: femoral triangle block | Procedure | Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance. |
|
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| 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. |
| 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. | 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 | 24.48,72 hours after surgery |
| Background |
| Song 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. |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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