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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultrasound-guided Intermediate Cervical Plexus Block

NCT02794974

Internal Carotid Artery Stenosis

COMPLETED NA

Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries: A Comparison Between Two Bupivacaine Concentrations

NCT06621836

Cervical Plexus Block

COMPLETED PHASE4

Inter-semispinal Plane Block and Cervical Spine Surgery

NCT06003933

Post Operative Pain Cervical Spine Instability

COMPLETED NA

Influence of the Concentration of the Local Anesthetic Ropivacaine on the Quality of a Ultrasound Guided Intermediate Cervical Block.

NCT01759940

Intermediate Cervical Plexus Block for Carotid Endarterectomy

COMPLETED PHASE4

Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method

NCT01608126

Cervical Plexus Block Comparison

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ropivacaine

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

Group Type ACTIVE_COMPARATOR

intermediate cervical plexus block ropivacaine

Intervention Type DRUG

20ml ultrasound guided intermediate cervical plexus block.

pericarotidal infiltration (active comparator) ropivacaine

Intervention Type DRUG

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

jugular infiltration prilocaine

Intervention Type DRUG

5ml prilocaine 1% jugular infiltration for wound drainage.

saline

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

Group Type PLACEBO_COMPARATOR

intermediate cervical plexus block ropivacaine

Intervention Type DRUG

20ml ultrasound guided intermediate cervical plexus block.

jugular infiltration prilocaine

Intervention Type DRUG

5ml prilocaine 1% jugular infiltration for wound drainage.

pericarotidal infiltration (placebo comparator) saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intermediate cervical plexus block ropivacaine

20ml ultrasound guided intermediate cervical plexus block.

Intervention Type DRUG

pericarotidal infiltration (active comparator) ropivacaine

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

Intervention Type DRUG

jugular infiltration prilocaine

5ml prilocaine 1% jugular infiltration for wound drainage.

Intervention Type DRUG

pericarotidal infiltration (placebo comparator) saline

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No