Knee Arthropathy, Knee Arthritis
Conditions
Keywords
Knee Arthropathy, liposome bupivacaine, femoral nerve block, adductor canal block
Brief 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. Is bupivacaine liposomes superior to bupivacaine in femoral triangle block or adductor block in terms of 72 hours opioid consumption after knee replacement 2. 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: 1. Receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance. 2. Undergo total knee replacement surgery under spinal anesthesia. 3. 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)).
Interventions
Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
PROCEDURENerve block mode : adductor block
Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance.
DRUGBupivacaine
Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
PROCEDURENerve block mode: femoral triangle block
Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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 .
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with ASAI-ⅲ 2. Receive a unilateral initial TKA 3. Age 18-80 years old -
Exclusion criteria
1. Bilateral TKA surgery 2. TKA revision surgery 3. Contraindications for nerve block and intraspinal anesthesia 4. Allergies to local anesthetics 5. Diabetic neuropathy 6. Patients who are unable to cooperate with the evaluation 7. Chronic use of opioid analgesics 8. BMI≥35kg/cm2 9. Cases of lumbar anesthesia failure requiring general anesthesia surgery 10. Cases of nerve block failure \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption 72 hours after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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 | 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 |
| Time to First Rescue Analgesic | 72 hours after surgery | 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. |
| Total opioid dosage and PCA times | 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 | The evaluation includes quantifying the amount of opioids prescribed and consumed PCA times by participants for pain management post-surgery. |
| Quadriceps muscle strength | 24.48,72 hours after surgery | The quadriceps muscle strength is measured with a hand-held dynamometer |
Countries
China
Contacts
Primary ContactLlingli deng, postgraduate
Outcome results
None listed