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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Arthritis; Knee Arthropathy
• Intervention / Treatment: Drug: Bupivacaine liposome; Procedure: Nerve block mode : adductor block; Drug: Bupivacaine; Procedure: Nerve block mode: femoral triangle block

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 Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Llingli deng, postgraduate; Phone Number: +86 18707159290; Email: 296890303@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Lingli DENG
      • Contact: lingli DENG, MD; Phone Number: +86 18707159290; Email: 296890303@qq.com
      • Contact: wei mei, MD; Phone Number: +86 13006162508; Email: 296890303@qq.com
      • Principal Investigator: WEI Mei, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 .	Drug: Bupivacaine liposome; Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.; Other Names: L; Procedure: Nerve block mode : adductor block; Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance.; Other Names: A
Active Comparator: adductor block+ bupivacaine; The patient underwent ultrasound-guided bupivacaine single adductor block during anesthesia induction room for analgesia after total knee arthroplasty	Procedure: Nerve block mode : adductor block; Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for adductor block under ultrasound guidance.; Other Names: A; Drug: Bupivacaine; Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.; Other Names: B
Experimental: 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 .	Drug: Bupivacaine liposome; Subjects receive liposomal bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.; Other Names: L; Procedure: Nerve block mode: femoral triangle block; Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance.; Other Names: F
Active Comparator: femoral triangle block + bupivacaine; The patient underwent ultrasound-guided bupivacaine single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty .	Drug: Bupivacaine; Subjects receive bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.; Other Names: B; Procedure: Nerve block mode: femoral triangle block; Subjects receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block under ultrasound guidance.; Other Names: F

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	this outcome will be monitored and recorded within 72 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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.	72 hours after surgery
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.	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
Quadriceps muscle strength	The quadriceps muscle strength is measured with a hand-held dynamometer	24.48,72 hours after surgery

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Wei Mei, MD, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

General Publications

• Chuan A, Lansdown A, Brick KL, Bourgeois AJG, Pencheva LB, Hue B, Goddard S, Lennon MJ, Walters A, Auyong D; Continuous Catheters in Adductor Canal versus Femoral Triangle (The CAFE study) investigators. Adductor canal versus femoral triangle anatomical locations for continuous catheter analgesia after total knee arthroplasty: a multicentre randomised controlled study. Br J Anaesth. 2019 Sep;123(3):360-367. doi: 10.1016/j.bja.2019.03.021. Epub 2019 May 2.
• Song L, Li Y, Xu Z, Geng ZY, Wang DX. Comparison of the ultrasound-guided single-injection femoral triangle block versus adductor canal block for analgesia following total knee arthroplasty: a randomized, double-blind trial. J Anesth. 2020 Oct;34(5):702-711. doi: 10.1007/s00540-020-02813-8. Epub 2020 Jun 12.

Study record dates

Study Major Dates

• Study Start (Estimated): November 5, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: femoral nerve block; adductor canal block; Knee Arthropathy; liposome bupivacaine
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: TJ-IRB202409095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No