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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Qilu Hospital of Shandong University Dezhou Hospital (Dezhou People's Hospital)
RECRUITING
Dezhou
Contact Information
Primary
Ke Song
sdycsk@126.com
+86-15628656839
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2024-09-15
Participants
Target number of participants: 60
Treatments
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.
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.
Sponsors
Leads: Dezhou Hospital Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov