The Efficacy of Personalized Local Anesthetic Dosing Based on Ultrasound-Measured Nerve Cross-Sectional Area in Brachial Plexus Block: a Non-Inferiority Randomized Controlled Trial.
Starting soon · Not applicable
Conditions studied: Upper Limb Surgery
In brief
This is a prospective, randomized, assessor-blinded, three-arm, non-inferiority clinical trial. The study aims to compare the effectiveness and safety of an individualized dosing strategy for local anesthetic in brachial plexus blocks against two standard methods. The experimental intervention uses ultrasound to measure the cross-sectional area (CSA) of the brachial plexus nerves to calculate a patient-specific dose of 0.5% ropivacaine. This is compared to a standard weight-based dosing regimen (2.5 mg/kg) and dosing based on the anesthesiologist's clinical experience. A total of 350 adult patients scheduled for elective unilateral upper limb surgery will be randomly assigned to one of the three groups. The primary outcome is the success rate of the nerve block 30 minutes after administration. Secondary outcomes include assessments of diaphragmatic function, postoperative pain scores, the incidence of complications (such as nerve involvement or systemic toxicity), and patient satisfaction. The hypothesis is that the CSA-based dosing method will be non-inferior to the conventional methods in achieving successful anesthesia while potentially optimizing drug dosage.
Key facts
- Study ID
- NCT07353047
- Run by
- Northern Jiangsu People's Hospital
- People needed
- 300
- Starts
- 2026-02-01
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-01-20
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-80 years old, proposed for elective unilateral upper extremity surgery; ASA grade I-III; Planned to undergo ultrasound-guided interscalene sulcus brachial plexus block; Normal preoperative respiratory function; No history of neck surgery; No use of drugs that affect nerve conduction or opioids within 30 days prior to surgery
You may not qualify if…
- Local infection, coagulation dysfunction, neuropathy; Allergy to ropivacaine or amide local anesthetics; Severe hepatic and renal insufficiency; Pregnancy or lactation; Expected dosing required to exceed the maximum safe single safe dose of ropivacaine; Inability to cooperate with ultrasound measurements or nerve block operators.
Where it is running
- Jianjun Qian — Yangzhou, Jiangsu, China
Full record on ClinicalTrials.gov
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