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NCT Number: NCT06653621

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

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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Key information

Conditions

Knee Arthropathy Knee Arthritis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Bupivacaine liposome

Drug

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

Other names: L

Nerve block mode : adductor block

Procedure

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

Other names: A

Bupivacaine

Drug

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

Other names: B

Nerve block mode: femoral triangle block

Procedure

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

Other names: F

Primary outcomes

  1. Opioid consumption 72 hours after surgery

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

    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.

Secondary outcomes

  1. 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

    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

  2. Time to First Rescue Analgesic

    Time frame: 72 hours after surgery

    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.

  3. 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

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

  4. Quadriceps muscle strength

    Time frame: 24.48,72 hours after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Llingli deng, postgraduate

CONTACT

[email protected]

+86 18707159290

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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