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

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ClinicalTrials.gov Identifier: NCT02336958
Recruitment Status : Completed
First Posted : January 13, 2015
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Dr.med.Ronald Seidel, Helios Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Drug: intermediate cervical plexus block ropivacaine Drug: pericarotidal infiltration (active comparator) ropivacaine Drug: jugular infiltration prilocaine Drug: pericarotidal infiltration (placebo comparator) saline Not Applicable

Detailed Description:

The innervation of the neck is complex and involves the cervical and the brachial plexus as well as cranial nerves. So is the wall of the carotid arteries innervated by vagal and glossopharyngeal nerve as well as the sympathetic trunk. When carotid surgery was performed under regional anesthesia, so additional infiltration of local anesthetic by the surgeon was common, particularly during preparation of the carotid arteries.

Introduction of ultrasound guidance made it possible to guide the needle directly to the vascular wall. But this procedure is considered very demanding, because of guiding the needle in an anatomical region with artifacts (because of calcification), sudden movements (e.g. because of swallowing) and compromised coagulation (antithrombotic medication). On the other side there are no clinical data proving the benefit of an additional perivascular infiltration with local anesthetic. Therefore, this investigation is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration
Study Start Date : September 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: ropivacaine
Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
Drug: intermediate cervical plexus block ropivacaine
20ml ultrasound guided intermediate cervical plexus block.

Drug: pericarotidal infiltration (active comparator) ropivacaine
5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.

Drug: jugular infiltration prilocaine
5ml prilocaine 1% jugular infiltration for wound drainage.

Placebo Comparator: saline
Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
Drug: intermediate cervical plexus block ropivacaine
20ml ultrasound guided intermediate cervical plexus block.

Drug: jugular infiltration prilocaine
5ml prilocaine 1% jugular infiltration for wound drainage.

Drug: pericarotidal infiltration (placebo comparator) saline
5ml saline 0.9% (placebo comparator): pericarotidal infiltration.




Primary Outcome Measures :
  1. Number of Patients With Required Supplementation of Local Anesthetic by Surgeon [ Time Frame: during the intraoperative period ]
  2. Amount (ml) of Local Anesthetic Supplemented by Surgeon [ Time Frame: during the intraoperative period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336958


Sponsors and Collaborators
Helios Research Center
Investigators
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Principal Investigator: Ronald Seidel, Dr.med. Helios Kliniken Schwerin, Klinik für Anästhesiologie und Intensivtherapie, Wismarsche Strasse 393-7, 19049 Schwerin, Germany

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Responsible Party: Dr.med.Ronald Seidel, MD, Helios Research Center
ClinicalTrials.gov Identifier: NCT02336958     History of Changes
Other Study ID Numbers: A 2013-0075
First Posted: January 13, 2015    Key Record Dates
Results First Posted: March 23, 2015
Last Update Posted: March 23, 2015
Last Verified: March 2015

Keywords provided by Dr.med.Ronald Seidel, Helios Research Center:
cervical plexus
regional anesthesia
ultrasound
carotid surgery

Additional relevant MeSH terms:
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Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Ropivacaine
Prilocaine
Anesthetics, Local
Physiological Effects of Drugs