Trials / Completed
CompletedNCT02336958
Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration
Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Helios Research Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | pericarotidal infiltration (placebo comparator) saline | 5ml saline 0.9% (placebo comparator): pericarotidal infiltration. |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2015-01-13
- Last updated
- 2015-03-23
- Results posted
- 2015-03-23
Source: ClinicalTrials.gov record NCT02336958. Inclusion in this directory is not an endorsement.