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Clinical Trials/NCT01742845
NCT01742845CompletedNot Applicable

Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid : a Randomised Controlled Trial

Centre Hospitalier Universitaire de Besancon1 site in 1 country86 target enrollmentStarted: April 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
1
Primary Endpoint
cervical block success

Study Overview

Brief Summary

The aim of this prospective, randomised, controlled study is to compare the efficacy of ultrasound-guided intermediate cervical block to superficial block for carotid endarterectomy.

Patients scheduled for carotide endarterectomy under regional anaesthesia (ropivacaine 4.75 mg/ml) are randomised into 2 groups according to the technique of anaesthesia performed: superficial cervical block (Control group) or, ultrasound guided intermediate cervical block (Echo group). Main outcome is cervical block success, defined by surgery performed under regional anaesthesia without supplemental topical lidocaine. Secondary outcomes are rate of conversion to general anaesthesia, total dose of supplemental topical lidocaine and block-related complications.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patient scheduled for elective carotid artery endarterectomy under regional anaesthesia

Exclusion Criteria

  • •indication for general anaesthesia
  • •known bleedind diathesis
  • •past medical allergy to local anaesthesic
  • •severe chronic pulmonary disease
  • •contralateral diaphragmatic motion abnormalities
  • •previous cervical ipsilateral surgery
  • •age < 18 years

Arms & Interventions

control group

Active Comparator

landmark-based superficial cervical block is used. After insertion of the needle superficially below the skin, 20 to 30 ml of 4.75 mg/ml ropivacaine are injected fan-like in the subcutaneus plane.

Intervention: landmark based superfical ropivacaine 4.75 mg/ml injection (Other)

echo group

Experimental

ultrasound-guided intermediate cervical block was performed. The probe is placed perpendicular to the skin, in the horizontal plane at the C3-C4 level. Needle is inserted in-plane. 10 ml ropivacaine 4.75mg/ml are injected under ultrasound control, 5 ml injected when needle is withdrawn under ultrasound control, 5 ml in the subcutaneous plane.

Intervention: Ultrasound-guided administration of ropivacaine 4.75 mg/ml (Other)

Outcomes

Primary Outcomes

cervical block success

Time Frame: surgery time

carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine.

Secondary Outcomes

  • percentage of conversion to general anaesthesia(surgery time)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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