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N/A N=40 Randomized Double-blind Treatment

Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration

Carotid Stenosis

Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Mar 2015
Primary outcome: Primary: Number of Patients With Required Supplementation of Local Anesthetic by Surgeon — 13; 13 participants — p=1.0

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
intermediate cervical plexus block ropivacaine (Drug); pericarotidal infiltration (active comparator) ropivacaine (Drug); jugular infiltration prilocaine (Drug); pericarotidal infiltration (placebo comparator) saline (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Helios Research Center
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Required Supplementation of Local Anesthetic by Surgeon
13; 13 1.0
PRIMARY
Amount (ml) of Local Anesthetic Supplemented by Surgeon
4.9; 3.7 0.459

Summary

For ultrasound guided intermediate cervical plexus block this randomized comparison is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

Eligibility Criteria

Inclusion Criteria

  • carotid surgery (symptomatic and asymptomatic carotid stenosis)
  • adult patients (18 years or older)
  • ASA-risk-groups I-IV
  • informed consent

Exclusion Criteria

  • drug allergy: local anesthetics
  • pregnancy, lactation period
  • participation in other studies
  • addiction to drugs or alcohol
  • non-cooperative patients
  • no approval to regional anesthesia
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02336958). 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.

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