Carotid Stenosis
Conditions
Keywords
cervical plexus, regional anesthesia, ultrasound, carotid surgery
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.
Interventions
DRUGintermediate cervical plexus block ropivacaine
20ml ultrasound guided intermediate cervical plexus block.
DRUGpericarotidal infiltration (active comparator) ropivacaine
5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
DRUGjugular infiltration prilocaine
5ml prilocaine 1% jugular infiltration for wound drainage.
DRUGpericarotidal infiltration (placebo comparator) saline
5ml saline 0.9% (placebo comparator): pericarotidal infiltration.
Sponsors
Helios Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount (ml) of Local Anesthetic Supplemented by Surgeon | during the intraoperative period |
| Number of Patients With Required Supplementation of Local Anesthetic by Surgeon | during the intraoperative period |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage. | 20 |
| Saline Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.
jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.
pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Ropivacaine | Total | Saline |
|---|---|---|---|
| Age, Continuous | 70.9 years STANDARD_DEVIATION 9 | 71.5 years STANDARD_DEVIATION 8.3 | 72.2 years STANDARD_DEVIATION 7.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 40 Participants | 20 Participants |
| Region of Enrollment Germany | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 13 Participants | 27 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 20 | 13 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 |
Outcome results
Primary
Amount (ml) of Local Anesthetic Supplemented by Surgeon
Time frame: during the intraoperative period
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ropivacaine | Amount (ml) of Local Anesthetic Supplemented by Surgeon | 4.9 ml |
| Saline | Amount (ml) of Local Anesthetic Supplemented by Surgeon | 3.7 ml |
p-value: 0.459t-test, 2 sided
Primary
Number of Patients With Required Supplementation of Local Anesthetic by Surgeon
Time frame: during the intraoperative period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ropivacaine | Number of Patients With Required Supplementation of Local Anesthetic by Surgeon | 13 participants |
| Saline | Number of Patients With Required Supplementation of Local Anesthetic by Surgeon | 13 participants |
p-value: 1Fisher Exact