Phase 1 N=110 Randomized Double-blind Basic Science

The Study of Regional Hemodynamic Changes After Specific Brachial Plexus Block by Ultrasound Guidance

Upper Limb Nerve Block

Bottom Line

View on ClinicalTrials.gov: NCT02139982 ↗

Enrolled (actual)

110

Serious AEs

—

Results posted

Jul 2014

Primary outcome: Primary: Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1) — 40.9; 39.6; 47.6; 42.6 cm/s

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: specific nerve block (Procedure); ropivacaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wenzhou Medical University
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)	40.9; 39.6; 47.6; 42.6; 40.7; 40.9	—
PRIMARY Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)	1.031371; 1.15; 1.19; 1.19; 1.29; 1.43	—
PRIMARY Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)	0.051; 0.051; 0.040; 0.051; 0.053; 0.053	—
SECONDARY Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)	30.0; 29.8; 30.2; 30.0; 29.9; 30.0	—
SECONDARY Success of Brachial Plexus Block ( Phase 2)	1; 9; 11; 12; 13; 13	—
SECONDARY Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)	1.18; 1.91; 2.27; 2.32; 2.44; 2.43	—

Summary

Phase 1 Sympathetic block leads to vasodilatation and increases in blood flow. However, regional hemodynamic changes of radial and ulnar artery after specific nerve block of brachial plexus remains unclear. The aim of the study is to assess the effect of specific nerve block of brachial plexus on hemodynamics of upper extremity, and provides evidence for further research in patient undergoing microvascular surgery. Phase 2 There is no literature about dose-finding studies of sympathetic block after brachial plexus block. Little is known regarding the relationship between concentration of local anaesthetic and vasodilation of upper extremity. The aim of this randomized, double-blind, prospective dose-response study is to determine the ED50 and ED95 of ropivacaine in sympathetic block of upper extremity after supraclavicular block

Eligibility Criteria

Inclusion Criteria

American Society of Anesthesiologist physical status I-III patients
aged 18-70 yr
weighing 40-80 kg

Exclusion Criteria

infection at the site of needle insertion
coagulopathy
international normalized ratio >1.4
platelet count <80×109 litre-1
allergy to local anaesthetics
peripheral neurological disease
peripheral vascular disease
patients do not agree to sign the informed consent.

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Data sourced from ClinicalTrials.gov (NCT02139982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.