Trial Outcomes & Findings for Ultrasound-guided Intermediate Cervical Plexus Block (NCT NCT02794974)
NCT ID: NCT02794974
Last Updated: 2018-12-19
Results Overview
number of participants who need supplementation of prilocaine 1% by the surgeon (%)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
intraoperatively
Results posted on
2018-12-19
Participant Flow
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.
Participant milestones
| Measure |
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%
|
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%
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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%
|
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%
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cervical Plexus, Perivascular and Facial Nerve Block
n=14 Participants
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%
|
Cervical Plexus and Facial Nerve Block
n=14 Participants
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%
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=28 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 9 • n=14 Participants
|
71 years
STANDARD_DEVIATION 10 • n=14 Participants
|
69 years
STANDARD_DEVIATION 9.5 • n=28 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=14 Participants
|
1 Participants
n=14 Participants
|
7 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=14 Participants
|
13 Participants
n=14 Participants
|
21 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: intraoperativelynumber of participants who need supplementation of prilocaine 1% by the surgeon (%)
Outcome measures
| Measure |
Cervical Plexus and Facial Nerve Block
n=14 Participants
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%
|
Cervical Plexus, Perivascular and Facial Nerve Block
n=14 Participants
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%
|
|---|---|---|
|
Local Anesthetic Supplementation (Frequency)
|
11 participants
|
7 participants
|
PRIMARY outcome
Timeframe: intraoperativelyvolume of prilocaine 1% supplemented by the surgeon (ml)
Outcome measures
| Measure |
Cervical Plexus and Facial Nerve Block
n=14 Participants
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%
|
Cervical Plexus, Perivascular and Facial Nerve Block
n=14 Participants
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%
|
|---|---|---|
|
Local Anesthetic Supplementation (Volume)
|
4.2 ml
Standard Deviation 3.1
|
1.7 ml
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: intraoperativelynumber of participants who experienced side effects: hoarseness
Outcome measures
| Measure |
Cervical Plexus and Facial Nerve Block
n=14 Participants
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%
|
Cervical Plexus, Perivascular and Facial Nerve Block
n=14 Participants
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%
|
|---|---|---|
|
Hoarseness
|
8 participants
|
12 participants
|
SECONDARY outcome
Timeframe: intraoperativelynumber of participants who experienced side effects: cough
Outcome measures
| Measure |
Cervical Plexus and Facial Nerve Block
n=14 Participants
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%
|
Cervical Plexus, Perivascular and Facial Nerve Block
n=14 Participants
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%
|
|---|---|---|
|
Cough
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: intraoperativelynumber of participants who experienced side effects: dysphagia
Outcome measures
| Measure |
Cervical Plexus and Facial Nerve Block
n=14 Participants
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%
|
Cervical Plexus, Perivascular and Facial Nerve Block
n=14 Participants
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%
|
|---|---|---|
|
Dysphagia
|
4 participants
|
6 participants
|
Adverse Events
Without Perivascular Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
With Perivascular Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ronald Seidel
HELIOS Medical Center Schwerin, Germany
Phone: +49 385 5204251
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place