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

Primary Purpose

Carotid Stenosis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

intermediate cervical plexus block ropivacaine

pericarotidal infiltration (active comparator) ropivacaine

jugular infiltration prilocaine

pericarotidal infiltration (placebo comparator) saline

About this trial

This is an interventional treatment trial for Carotid Stenosis focused on measuring cervical plexus, regional anesthesia, ultrasound, carotid surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ropivacaine

saline

Arm Description

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.

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

Outcomes

Primary Outcome Measures

Number of Patients With Required Supplementation of Local Anesthetic by Surgeon

Amount (ml) of Local Anesthetic Supplemented by Surgeon

Secondary Outcome Measures

Full Information

NCT ID

NCT02336958

First Posted

January 2, 2015

Last Updated

March 12, 2015

Sponsor

Helios Research Center

1. Study Identification

Unique Protocol Identification Number

NCT02336958

Brief Title

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

Official Title

Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helios Research Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Stenosis

Keywords

cervical plexus, regional anesthesia, ultrasound, carotid surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ropivacaine

Arm Type

Active Comparator

Arm Description

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.

Arm Title

saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

intermediate cervical plexus block ropivacaine

Intervention Description

20ml ultrasound guided intermediate cervical plexus block.

Intervention Type

Drug

Intervention Name(s)

pericarotidal infiltration (active comparator) ropivacaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

jugular infiltration prilocaine

Intervention Description

5ml prilocaine 1% jugular infiltration for wound drainage.

Intervention Type

Drug

Intervention Name(s)

pericarotidal infiltration (placebo comparator) saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Patients With Required Supplementation of Local Anesthetic by Surgeon

Time Frame

during the intraoperative period

Title

Amount (ml) of Local Anesthetic Supplemented by Surgeon

Time Frame

during the intraoperative period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Seidel, Dr.med.

Organizational Affiliation

Helios Kliniken Schwerin, Klinik für Anästhesiologie und Intensivtherapie, Wismarsche Strasse 393-7, 19049 Schwerin, Germany

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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