Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement

Huazhong University of Science and Technology

Status and phase: Not yet enrolling; Phase 4

Conditions: Knee Arthritis; Knee Arthropathy

Treatments: Procedure: Nerve block mode: femoral triangle block; Drug: Bupivacaine; Drug: Bupivacaine liposome; Procedure: Nerve block mode : adductor block

Study type: Interventional

Funder types: Other

Identifiers

NCT06653621

TJ-IRB202409095

Details and patient eligibility

About

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

Full 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)).

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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144 participants in 4 patient groups

adductor block+ Bupivacaine liposomes and bupivacaine mixture

Experimental group

Description:

The patient underwent ultrasound-guided bupivacaine liposome mixture single adductor block during anesthesia induction room for analgesia after total knee arthroplasty .

Treatment:

Procedure: Nerve block mode : adductor block

Drug: Bupivacaine liposome

adductor block+ bupivacaine

Active Comparator group

Description:

The patient underwent ultrasound-guided bupivacaine single adductor block during anesthesia induction room for analgesia after total knee arthroplasty

Treatment:

Procedure: Nerve block mode : adductor block

Drug: Bupivacaine

femoral triangle block + Bupivacaine liposomes and bupivacaine mixture

Experimental group

Description:

The patient underwent ultrasound-guided bupivacaine liposome mixture single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty .

Treatment:

Drug: Bupivacaine liposome

Procedure: Nerve block mode: femoral triangle block

femoral triangle block + bupivacaine

Active Comparator group

Description:

The patient underwent ultrasound-guided bupivacaine single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty .

Treatment:

Procedure: Nerve block mode: femoral triangle block

Drug: Bupivacaine