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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHuazhong University of Science and Technology

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with ASAI-ⅲ

Receive a unilateral initial TKA

Age 18-80 years old -

Disqualifiers

Bilateral TKA surgery

TKA revision surgery

Contraindications for nerve block and intraspinal anesthesia

Allergies to local anesthetics

Trial design

Design model

Factorial

Treatments tested in this trial

  • Bupivacaine liposome

    Drug

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

  • Nerve block mode : adductor block

    Procedure/Surgery

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

  • Bupivacaine

    Drug

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

  • Nerve block mode: femoral triangle block

    Procedure/Surgery

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

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: adductor block+ Bupivacaine liposomes and bupivacaine mixtureExperimental treatment 2 interventions
Group B: adductor block+ bupivacaineActive comparator 2 interventions
Group C: femoral triangle block + Bupivacaine liposomes and bupivacaine mixtureExperimental treatment 2 interventions
Group D: femoral triangle block + bupivacaineActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Opioid consumption 72 hours after surgery

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.

Time frame
this outcome will be monitored and recorded within 72 hours postoperatively

Secondary outcomes

1

Pain intensity

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 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
2

Time to First Rescue Analgesic

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.

Time frame
72 hours after surgery
3

Total opioid dosage and PCA times

The evaluation includes quantifying the amount of opioids prescribed and consumed PCA times by participants for pain management post-surgery.

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
4

Quadriceps muscle strength

The quadriceps muscle strength is measured with a hand-held dynamometer

Time frame
24.48,72 hours after surgery

Other outcomes

Sponsors and contacts

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