Efficacy and Safety of Liposomal Bupivacaine and Ropivacaine in Upper Limb Surgery
ConditionUpper Limb Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorXiaguang Duan
About this trial
This clinical trial aims to evaluate the efficacy and safety of liposomal bupivacaine and ropivacaine when used in different brachial plexus blocks and epidural anesthesia for the management of pain associated with burn injuries, digital replantation, and upper limb fractures (including radial, ulnar, humeral, and carpal fractures), as well as hand fractures (including phalangeal and metacarpal fractures). The primary objective is to determine whether liposomal bupivacaine or ropivacaine reduces the required postoperative analgesic dosage in these patient populations.
Specifically, this study will compare brachial plexus blockade with either liposomal bupivacaine or ropivacaine, combined with general anesthesia, against general anesthesia alone to assess the effectiveness of these two local anesthetics in achieving postoperative analgesia.
Enrolled participants will be randomized to one of two treatment arms: either brachial plexus block followed by endotracheal intubation and general anesthesia or general anesthesia alone. Postoperative vital signs, analgesic requirements, and recovery parameters will be continuously monitored and recorded.
Eligibility criteria
Qualifiers
Age: Two years or older.
ASA Physical Status: American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
Surgical Indication: Patients requiring surgical treatment for any of the following upper limb injuries: Burn injuries. Digital replantation. Upper limb fractures, including fractures of the radius, ulna, humerus, and carpal bones. Hand fractures, including fractures of the phalanges and metacarpals.
Patients scheduled to undergo either a continuous brachial plexus block combined with general anesthesia or general anesthesia alone.
Disqualifiers
Known allergy to local anesthetic agents.
Presence of infection or skin disease at the planned puncture site.
Severe coagulation disorders or current use of anticoagulant medications that cannot be safely discontinued for the procedure.
Presence of severe cardiopulmonary or neurological disease.
Trial design
Treatments tested in this trial
- General Anesthesia (GA)
- Continuous Brachial Plexus Block
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xiaguang Duan
Lead sponsor
Inner Mongolia Baogang Hospital
Sponsor institution
Source ClinicalTrials.gov