Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty

Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection for in Total Knee Arthroplasty: a Prospective, Randomized, Controlled Study

The goal of this clinical trial is to learn if drug Bupivacaine liposomes works better than traditional peri-articular injection for Control of Pain in Total Knee Arthroplasty. It will also learn about the safety of drug Bupivacaine liposomes.

The main questions it aims to answer are:

Does Bupivacaine liposomes works better than traditional peri-articular injection for Control of Pain in Total Knee Arthroplasty.

Researchers will compare Bupivacaine liposomes to traditional peri-articular injection to see if drug Bupivacaine liposomes works better for Control of Pain in Total Knee Arthroplasty

Participants will:

Receive peri-articular injection in total Knee Arthroplasty. checkups and tests During hospitalization.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: liposomal bupivacaine; Drug: traditional peri-articular injection

Detailed Description

Total knee replacement (TKA) has made significant progress in the treatment of chronic intractable joint pain, and now the fastest effective way to treat serious knee diseases is to perform artificial knee replacement (TKA). Pain is an important factor affecting patients' satisfaction with TKA surgery, and it is also a key factor affecting patients' postoperative rehabilitation and reducing surgical complications.

Effective analgesia program can not only improve the postoperative satisfaction of patients, reduce the use of analgesic drugs, reduce postoperative adverse reactions, but also shorten the length of hospitalization and reduce hospitalization costs. Local Infiltration Analgesia (LIA) is a simple and effective analgesia technique that involves the infiltration of drugs into the wound during surgery. The duration of the analgesic effect can be prolonged by precisely placing the catheter at the surgical site for further local anesthesia after surgery. The most commonly used drugs for intra-articular and extra-articular injections are morphine, steroids, clonidine, epinephrine, ketorolac, ropivacaine, and bupivacaine.

Bupivacaine liposomes, as a new formulation of long-acting sustained-release bupivacaine, are of great significance for multimodal analgesia after TKA. At present, there are no studies on the application of bupivacaine liposomes and knee replacement in China. The purpose of this study was to observe the analgesic effect and effect on function of bupivacaine liposome used in local infiltration analgesia after total knee replacement, and to explore its analgesic effectiveness and safety, so as to provide some reference for the selection of analgesia for total knee replacement.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ke Song; Phone Number: +86-15628656839; Email: sdycsk@126.com

Study Locations

• China
  • Shandong
    • Dezhou, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University Dezhou Hospital (Dezhou People's Hospital)
      • Contact: ke song

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Male or female, age ≥ 18 years.
2. American Society of Anesthesiologists (ASA) classification of grade I-II, with a certain level of literacy, good comprehension of Chinese language and text, no obstacles in doctor-patient communication, good understanding of visual analog scoring of pain (VAS scoring), and the ability to actively cooperate with the relevant examinations
3. Proposed initial unilateral total knee arthroplasty (TKA) under general anesthesia without any previous history of knee surgery.
4. The patients will participate in the study voluntarily, sign an informed consent form, and cooperate with all the assessments.

Exclusion Criteria:

1. Patients with other pain management options prior to surgery
2. Patients with neuromuscular pathology in the operated limb with other comorbidities that may affect postoperative recovery
3. Patients with allergy, hypersensitivity, intolerance, or contraindication to any of the drugs on study
4. Patients with a history of coronary artery, vascular stent placement, deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke treated within the past 6 months
5. The existence of serious liver and kidney dysfunction, coagulation disorders, cardiac arrhythmia, infection and other contraindications to surgery；
6. patients with any neurological or psychiatric disorders that may affect postoperative pain or interfere with study evaluation；
7. Patients with a history of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: liposomal bupivacaine (LB) group; 20cc liposomal bupivacaine (1 vial; 266 mg) added to 30 cc normal saline to a total of 50 cc solution was injected into the periarticular tissues at the conclusion of the surgical procedure.	Drug: liposomal bupivacaine; liposomal bupivacaine group
Active Comparator: traditional peri-articular injection group; From periarticular injection consisted of 400 mg ropivacaine, 5 mg morphine and 0.4 mg epinephrine in 50 cc solution.	Drug: traditional peri-articular injection; traditional peri-articular injection group; Other Names: Cocktail injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The VAS scores	The VAS scores at 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours in the resting state and exercise state of the two groups were recorded	6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours

Collaborators and Investigators

• Sponsor: Dezhou Hospital Qilu Hospital of Shandong University
• Investigators: Study Chair: Peilai Liu, Qilu Hospital of Shandong University Dezhou Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: DZSRMYYZC2023133

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
• product manufactured in and exported from the U.S.: No