Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557018
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-13
Brief Title:
Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection for in Total Knee Arthroplasty a Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None