An interventional study of General Anesthesia (GA) and Continuous Brachial Plexus Block in Upper Limb Injury, sponsored by Xiaguang Duan. Not yet recruiting at 1 site in China. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Xiaguang Duan · Not applicable, Interventional, and Treatment
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.
Study Design: This study employed a prospective, randomized, comparative, and double-blinded design to assess the superiority and non-inferiority of brachial plexus blockade combined with general anesthesia versus general anesthesia alone for postoperative analgesia in patients with upper limb injuries. Patient recruitment was conducted at Baogang Hospital, Inner Mongolia. This study was approved by the Medical Ethics Committee of Baogang Hospital, Inner Mongolia, and adhered to the principles of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All participants provided informed consent prior to enrollment.
Patients: Sixty patients aged two years or older with American Society of Anesthesiologists (ASA) physical status classifications I to III, scheduled for surgery due to upper limb injuries between February 2025 and May 2025, were enrolled in this study. Participants were randomly assigned to one of two groups, each containing 30 patients, receiving either brachial plexus blockade combined with general anesthesia or general anesthesia alone.
Randomization and Blinding：This study employed block randomization to generate the random allocation sequence. A block size of 6 was set, and the random sequence was generated using dedicated software (the blockrand package in R version 4.3.2). The allocation of the random sequence was performed by an independent third party, and allocation concealment was implemented using sequentially numbered, sealed, opaque envelopes. The research team remained blinded throughout the randomization process and was not involved in the generation or allocation of the random sequence.
Intervention：Upon arrival to the operating room, patients will be monitored with electrocardiography, blood pressure, and pulse oximetry. Patients will be placed in the prone position with their arms abducted and internally rotated. Ultrasound guidance will be used for all regional anesthesia procedures (SonoSite Edge II; Fujifilm SonoSite, Bothell, WA, USA) with a linear 13-6 MHz ultrasound probe (HFL50x; Fujifilm SonoSite, Bothell, WA, USA). For each block, a 5 mL test dose will be injected initially, followed by observation for clinical signs of a successful block. After confirming correct placement, the remaining dose of the anesthetic agent will be injected. Following administration of the regional anesthesia, general anesthesia with endotracheal intubation will be performed. Anesthesia 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 Procedure: Patients 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.
Outcomes and Measures: Postoperative assessments were conducted in the ward by two nurses blinded to group assignment and specifically trained in the study protocols. These nurses performed in-person evaluations at the following time points: pre-treatment (baseline), and then postoperatively at 2 hours, 6 hours, 12 hours, and 24 hours.
63 studies on the registry are indexed under Arm Injuries; 10 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 44 interventional studies indexed under Arm Injuries.
Browse Arm Injuries studies →Xiaguang Duan is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
General anesthesia group. Anesthesia 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%.
Device: General Anesthesia (GA)
Patients 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.
Device: General Anesthesia (GA) · Device: Continuous Brachial Plexus Block
Anesthesia 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%.
Patients 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.
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.
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.
Postoperative Nausea and Vomiting (PONV)
The incidence and severity of nausea and vomiting experienced by patients after surgery.
Time frame: At 24 hours after surgery
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 surgery
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.
Plan to share: Yes — Only IPD used in the results publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: January 2026-January 2031
Access criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for May 2025, 3 months later.
Of 28 non-industry interventional studies with no phase under Arm Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 3 months is below that.
Counting every sponsor, half of 28 studies reached it within 24 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xiaguang Duan