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

NCT06557018 | Recruiting Phase 4

• 1 other identifier: DZSRMYYZC2023133
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

liposomal bupivacaine (LB) group

EXPERIMENTAL

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

traditional peri-articular injection group

ACTIVE COMPARATOR

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

Interventions

liposomal bupivacaine DRUG

liposomal bupivacaine group

liposomal bupivacaine (LB) group

traditional peri-articular injection DRUG

traditional peri-articular injection group

Also known as: Cocktail injection

traditional peri-articular injection group

Eligibility Criteria

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

You may qualify if:

• Male or female, age ≥ 18 years.
• 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
• Proposed initial unilateral total knee arthroplasty (TKA) under general anesthesia without any previous history of knee surgery.
• The patients will participate in the study voluntarily, sign an informed consent form, and cooperate with all the assessments.

You may not qualify if:

• Patients with other pain management options prior to surgery
• Patients with neuromuscular pathology in the operated limb with other comorbidities that may affect postoperative recovery
• Patients with allergy, hypersensitivity, intolerance, or contraindication to any of the drugs on study
• 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
• The existence of serious liver and kidney dysfunction, coagulation disorders, cardiac arrhythmia, infection and other contraindications to surgery；
• patients with any neurological or psychiatric disorders that may affect postoperative pain or interfere with study evaluation；
• Patients with a history of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol.

Sponsors & Collaborators

• Dezhou Hospital Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University Dezhou Hospital (Dezhou People's Hospital)

Dezhou, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Peilai Liu

  Dezhou Hospital Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Ke Song

CONTACT

+86-15628656839; sdycsk@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: August 16, 2024
• Study Start: June 25, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 15, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)