Internal Carotid Artery Stenosis
Conditions
Brief summary
The investigators test with the present study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.
Detailed description
The innervation of the neck area is complex and includes cranial nerve (innervation of the vessel wall (IX,X) and of the neck muscles (VII,XI)), as well as the cervical plexus and brachial plexus. This is a major cause of insufficient anesthesia quality during carotid endarterectomies. The investigators test with the present prospective study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.
Interventions
ultrasound-guided application of 20ml ropivacaine 0.75%
OTHERfacial nerve block
ultrasound-guided application of 5ml prilocaine 1%
OTHERperivascular block
ultrasound-guided application of 5ml prilocaine 1%
Sponsors
Helios Research Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* internal carotid stenosis: open surgical revascularization * age over 18 years * written informed consent
Exclusion criteria
* allergy (local anesthetics) * pregnancy * participation in other studies * drug addiction * non-cooperative patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Anesthetic Supplementation (Frequency) | intraoperatively | number of participants who need supplementation of prilocaine 1% by the surgeon (%) |
| Local Anesthetic Supplementation (Volume) | intraoperatively | volume of prilocaine 1% supplemented by the surgeon (ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hoarseness | intraoperatively | number of participants who experienced side effects: hoarseness |
| Cough | intraoperatively | number of participants who experienced side effects: cough |
| Dysphagia | intraoperatively | number of participants who experienced side effects: dysphagia |
Countries
Germany
Participant flow
Recruitment details
The patients were recruited as part of the preoperative information discussion. All patients received an intermediate cervical plexus block and a facial nerve block (cervical branch, superficial cervical ansa). The decision on an additional perivascular infiltration was made by an experienced physician on the basis of sonoanatomic properties.
Participants by arm
| Arm | Count |
|---|---|
| Cervical Plexus, Perivascular and Facial Nerve Block 1\. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%) 3. perivascular local anesthetic infiltration (5ml prilocaine 1%)
cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%
facial nerve block: ultrasound-guided application of 5ml prilocaine 1%
perivascular block: ultrasound-guided application of 5ml prilocaine 1% | 14 |
| Cervical Plexus and Facial Nerve Block 1\. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%)
cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75%
facial nerve block: ultrasound-guided application of 5ml prilocaine 1% | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Cervical Plexus and Facial Nerve Block | Total | Cervical Plexus, Perivascular and Facial Nerve Block |
|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 10 | 69 years STANDARD_DEVIATION 9.5 | 67 years STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Germany | 14 Participants | 28 Participants | 14 Participants |
| Sex: Female, Male Female | 1 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Male | 13 Participants | 21 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Local Anesthetic Supplementation (Frequency)
number of participants who need supplementation of prilocaine 1% by the surgeon (%)
Time frame: intraoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervical Plexus and Facial Nerve Block | Local Anesthetic Supplementation (Frequency) | 11 participants |
| Cervical Plexus, Perivascular and Facial Nerve Block | Local Anesthetic Supplementation (Frequency) | 7 participants |
p-value: 0.236Fisher Exact
Primary
Local Anesthetic Supplementation (Volume)
volume of prilocaine 1% supplemented by the surgeon (ml)
Time frame: intraoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervical Plexus and Facial Nerve Block | Local Anesthetic Supplementation (Volume) | 4.2 ml | Standard Deviation 3.1 |
| Cervical Plexus, Perivascular and Facial Nerve Block | Local Anesthetic Supplementation (Volume) | 1.7 ml | Standard Deviation 2 |
p-value: 0.018Wilcoxon (Mann-Whitney)
Secondary
Cough
number of participants who experienced side effects: cough
Time frame: intraoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervical Plexus and Facial Nerve Block | Cough | 4 participants |
| Cervical Plexus, Perivascular and Facial Nerve Block | Cough | 7 participants |
p-value: 0.4495% CI: [0.49, 12.77]Odds Ratio
Secondary
Dysphagia
number of participants who experienced side effects: dysphagia
Time frame: intraoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervical Plexus and Facial Nerve Block | Dysphagia | 4 participants |
| Cervical Plexus, Perivascular and Facial Nerve Block | Dysphagia | 6 participants |
p-value: 0.69595% CI: [0.37, 9.45]Odds Ratio
Secondary
Hoarseness
number of participants who experienced side effects: hoarseness
Time frame: intraoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervical Plexus and Facial Nerve Block | Hoarseness | 8 participants |
| Cervical Plexus, Perivascular and Facial Nerve Block | Hoarseness | 12 participants |
p-value: 0.20995% CI: [0.63, 32.2]Odds Ratio