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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
General Anesthesia (GA)
DeviceAnesthesia induction will be achieved using propofol (1.5-2 mg/kg i.v.), rocuronium (1-2 mg/kg i.v.), and fentanyl (1-2 μg/kg i.v.). Anesthesia will be maintained using sevoflurane or desflurane, with inhaled concentration adjusted based on Bispectral Index (BIS) monitoring. A continuous infusion of remifentanil (0.05-0.2 μg/kg/min) will be administered, with adjustments to maintain blood pressure and heart rate within ±20% of baseline values. Following induction, patients will be mechanically ventilated in pressure-regulated volume control (PRVC) mode. The ventilator (Aestiva; GE Healthcare, Waukesha, Wisconsin, USA) settings will be: tidal volume 6-8 mL/kg, positive end-expiratory pressure 0 cm H2O, inspiratory to expiratory ratio 1:2, respiratory rate 16 breaths per minute (BPM), and fraction of inspired oxygen 41%.
Continuous Brachial Plexus Block
DevicePatients were positioned supine with the head slightly turned to the contralateral side to expose the supraclavicular fossa. The injection site was prepared using standard aseptic techniques. Under ultrasound guidance, a needle was advanced to the vicinity of the brachial plexus. Aspiration was performed to confirm the absence of blood return before the slow, incremental injection of either liposomal bupivacaine \[adult dose: 133 mg (10 mL) to 266 mg (20 mL)\] or ropivacaine \[adult dose: 20 mL of 0.5% ropivacaine, administered via continuous infusion at a rate of 5-10 mL/h; pediatric dose: 0.1% ropivacaine at 0.1-0.2 mL/kg, administered via continuous infusion at 0.05-0.15 mL/kg/h\]. Patient responses were closely monitored throughout the procedure.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: GA groupExperimental treatment 1 intervention
Group B: CBPB groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Numerical Rating Scale(NRS)
The NRS, Numerical Rating Scale, is a rating system from 0 to 10, where 0 represents "no pain" and 10 represents the worst possible pain.
Time frame
At baseline (before therapy),At 2hours post-surgery, At 6hours post-surgery、At 12hours post-surgery、At 24hours post-surgery.Secondary outcomes
1
Total Postoperative Analgesic Consumption
The total amount of analgesic medication (including opioids and non-opioids, converted to morphine equivalents if necessary) used by patients from the end of surgery up to 24 hours post-surgery.
Time frame
At 24 hours post-surgery.2
Postoperative Nausea and Vomiting (PONV)
The incidence and severity of nausea and vomiting experienced by patients after surgery.
Time frame
At 24 hours after surgery3
Patient Satisfaction Score
Patient satisfaction with postoperative analgesia was assessed using a structured satisfaction survey. This survey employed a 10-point numerical rating scale, where 0 indicated complete dissatisfaction and 10 represented the highest level of satisfaction. The survey instrument encompassed evaluations of several key dimensions, including pain control, comfort, and the level of trust in the medical team.
Time frame
At 24 hours after surgery4
Postoperative Recovery Status
Assessment of patient recovery status, including consciousness level, respiratory status, circulatory status, and overall well-being after surgery.
Time frame
From the end of anesthesia up to 24 hours post-surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiaguang Duan
Lead sponsor
Inner Mongolia Baogang Hospital
Sponsor institution
Source ClinicalTrials.gov
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