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

Phase 4

Not yet recruiting

• Conditions: Knee Arthropathy; Knee Arthritis
• Interventions: Drug: Bupivacaine liposome; Drug: Bupivacaine

• Registration Number: NCT06653621
• Lead Sponsor: Huazhong University of Science and Technology

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)).

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-22
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Study Start: 2024-11-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
adductor block+ Bupivacaine liposomes and bupivacaine mixture	Bupivacaine liposome	The patient underwent ultrasound-guided bupivacaine liposome mixture single adductor block during anesthesia induction room for analgesia after total knee arthroplasty .
adductor block+ bupivacaine	Bupivacaine	The patient underwent ultrasound-guided bupivacaine single adductor block during anesthesia induction room for analgesia after total knee arthroplasty
femoral triangle block + Bupivacaine liposomes and bupivacaine mixture	Bupivacaine liposome	The patient underwent ultrasound-guided bupivacaine liposome mixture single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty .
femoral triangle block + bupivacaine	Bupivacaine	The patient underwent ultrasound-guided bupivacaine single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty .

Primary Outcome Measures

Name	Time	Method
Opioid consumption 72 hours after surgery	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 Outcome Measures

Name	Time	Method
Pain intensity	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
Time to First Rescue Analgesic	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.
Total opioid dosage and PCA times	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.
Quadriceps muscle strength	24.48,72 hours after surgery	The quadriceps muscle strength is measured with a hand-held dynamometer

Trial Locations

Locations (1)

Lingli DENG; 🇨🇳 Wuhan, Hubei, China