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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-05

Study Completion Date

2025-12-31

Brief Summary

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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:

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

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Detailed Description

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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)).

Conditions

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Knee Arthropathy Knee Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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adductor block+ Bupivacaine liposomes and bupivacaine mixture

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

Group Type EXPERIMENTAL

Bupivacaine liposome

Intervention Type DRUG

Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.

Nerve block mode : adductor block

Intervention Type PROCEDURE

Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance.

adductor block+ bupivacaine

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

Group Type ACTIVE_COMPARATOR

Nerve block mode : adductor block

Intervention Type PROCEDURE

Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance.

Bupivacaine

Intervention Type DRUG

Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.

femoral triangle block + Bupivacaine liposomes and bupivacaine mixture

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

Group Type EXPERIMENTAL

Bupivacaine liposome

Intervention Type DRUG

Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.

Nerve block mode: femoral triangle block

Intervention Type PROCEDURE

Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance.

femoral triangle block + bupivacaine

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.

Nerve block mode: femoral triangle block

Intervention Type PROCEDURE

Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance.

Interventions

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Bupivacaine liposome

Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.

Intervention Type DRUG

Nerve block mode : adductor block

Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance.

Intervention Type PROCEDURE

Bupivacaine

Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.

Intervention Type DRUG

Nerve block mode: femoral triangle block

Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance.

Intervention Type PROCEDURE

Other Intervention Names

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L A B F

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No