Clinical trial NCT06653621: Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Knee Arthropathy
Knee Arthritis
Keywords: Knee Arthropathy
liposome bupivacaine
femoral nerve block
adductor canal block
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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 .
Primary purpose: TREATMENT

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)).

Eligibility criteria: 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

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Primary outcomes:
measure: Opioid consumption 72 hours after surgery
timeFrame: this outcome will be monitored and recorded within 72 hours postoperatively
Secondary outcomes:
measure: Pain intensity
timeFrame: 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
measure: Time to First Rescue Analgesic
timeFrame: 72 hours after surgery
measure: Total opioid dosage and PCA times
timeFrame: 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
measure: Quadriceps muscle strength
timeFrame: 24.48,72 hours after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Lingli DENG
state: Hubei
Study officials:
affiliation: Tongji Medical College, Huazhong University of Science and Technology
name: wei mei, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.