Efficacy and Safety of Liposomal Bupivacaine and Ropivacaine in Upper Limb Surgery

NCT06779643 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2024-MER-319
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Limb Injury

Outcome Measures

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.

  At baseline (before therapy),At 2hours post-surgery, At 6hours post-surgery、At 12hours post-surgery、At 24hours post-surgery.

Secondary Outcomes (4)

• Total Postoperative Analgesic Consumption

  At 24 hours post-surgery.

• Postoperative Nausea and Vomiting (PONV)

  At 24 hours after surgery

• Patient Satisfaction Score

  At 24 hours after surgery

• Postoperative Recovery Status

  From the end of anesthesia up to 24 hours post-surgery.

Study Arms (2)

GA group

EXPERIMENTAL

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)

CBPB group

EXPERIMENTAL

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

Interventions

General Anesthesia (GA) DEVICE

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%.

CBPB group; GA group

Continuous Brachial Plexus Block DEVICE

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.

CBPB group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients (or their legal guardians) provided voluntary written informed consent.

You may not qualify if:

• 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.
• Inability to cooperate with regional or general anesthesia.
• Pregnancy or lactation.
• Presence of severe psychiatric illness or cognitive impairment that would hinder participation.
• Long-term use of analgesic medications.

Sponsors & Collaborators

• Xiaguang Duan: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Conditions

Arm Injuries

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Xiangyu Wang, MM

  Inner Mongolia Baogang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaguang Duan, Master's degree

CONTACT

+86 13314720012; alonlord2023@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Anesthesiology

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 16, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 10, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

CN (1)