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

NCT06653621 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: TJ-IRB202409095
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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. 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. 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.
3. 3.Receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
4. 4.Undergo total knee replacement surgery under spinal anesthesia.
5. 5.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

Conditions

Knee Arthropathy; Knee Arthritis

Keywords

Knee Arthropathy; liposome bupivacaine; femoral nerve block; adductor canal block

Outcome Measures

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.

  this outcome will be monitored and recorded within 72 hours postoperatively

Secondary Outcomes (4)

• 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

• Time to First Rescue Analgesic

  72 hours after surgery

• 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

• Quadriceps muscle strength

  24.48,72 hours after surgery

Study Arms (4)

adductor block+ Bupivacaine liposomes and bupivacaine mixture

EXPERIMENTAL

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

Drug: Bupivacaine liposome; Procedure: Nerve block mode : adductor block

adductor block+ bupivacaine

ACTIVE COMPARATOR

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; Drug: Bupivacaine

femoral triangle block + Bupivacaine liposomes and bupivacaine mixture

EXPERIMENTAL

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; Procedure: Nerve block mode: femoral triangle block

femoral triangle block + bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine; Procedure: Nerve block mode: femoral triangle block

Interventions

Bupivacaine liposome DRUG

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

Also known as: L

adductor block+ Bupivacaine liposomes and bupivacaine mixture; femoral triangle block + Bupivacaine liposomes and bupivacaine mixture

Nerve block mode : adductor block PROCEDURE

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

Also known as: A

adductor block+ Bupivacaine liposomes and bupivacaine mixture; adductor block+ bupivacaine

Bupivacaine DRUG

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

Also known as: B

adductor block+ bupivacaine; femoral triangle block + bupivacaine

Nerve block mode: femoral triangle block PROCEDURE

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

Also known as: F

femoral triangle block + Bupivacaine liposomes and bupivacaine mixture; femoral triangle block + bupivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ASAI-ⅲ
• Receive a unilateral initial TKA
• Age 18-80 years old -

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Lingli DENG

Wuhan, Hubei, 430030, China

Location

Related Publications (2)

• 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.

  PMID: 31056239 BACKGROUND

• 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.

  PMID: 32533332 BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• wei mei, MD

  Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Llingli deng, postgraduate

CONTACT

+86 18707159290; 296890303@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: 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 .

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 22, 2024
• Study Start: November 5, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)