Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine liposome, Nerve block mode : adductor block, Bupivacaine, Nerve block mode: femoral triangle block.
- Who it may be relevant to
- Registry conditions: Knee Arthropathy, Knee Arthritis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Bupivacaine liposome
Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance. - Procedure Nerve block mode : adductor block
Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance. - Drug Bupivacaine
Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance. - Procedure Nerve block mode: femoral triangle block
Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance.
Primary outcome measures
- Opioid consumption 72 hours after surgery [Time frame: this outcome will be monitored and recorded within 72 hours postoperatively]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- Patients with ASAI-ⅲ
- Receive a unilateral initial TKA
- Age 18-80 years old -
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Lingli DENG — Wuhan
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 PMID 31056239
- 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. PMID 32533332
Identifiers
NCT: NCT06653621 · TJ-IRB202409095