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Trial record 1 of 15 for:    "Carotid Stenosis" | "Peripheral Nervous System Agents"
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Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration

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ClinicalTrials.gov Identifier: NCT02336958
Recruitment Status : Completed
First Posted : January 13, 2015
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Dr.med.Ronald Seidel, Helios Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Carotid Stenosis
Interventions Drug: intermediate cervical plexus block ropivacaine
Drug: pericarotidal infiltration (active comparator) ropivacaine
Drug: jugular infiltration prilocaine
Drug: pericarotidal infiltration (placebo comparator) saline
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ropivacaine Saline
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Ropivacaine Saline Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
70.9  (9.0) 72.2  (7.7) 71.5  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
7
  35.0%
6
  30.0%
13
  32.5%
Male
13
  65.0%
14
  70.0%
27
  67.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
20
 100.0%
20
 100.0%
40
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Number of Patients With Required Supplementation of Local Anesthetic by Surgeon
Hide Description [Not Specified]
Time Frame during the intraoperative period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ropivacaine Saline
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
13 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine, Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Amount (ml) of Local Anesthetic Supplemented by Surgeon
Hide Description [Not Specified]
Time Frame during the intraoperative period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ropivacaine Saline
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: ml
4.9
(2.2 to 7.6)
3.7
(1.7 to 5.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine, Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.459
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame during the intraoperative period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ropivacaine Saline
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Ropivacaine Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ropivacaine Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/20 (0.00%)    
Nervous system disorders     
definitive stroke   1/20 (5.00%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ropivacaine Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/20 (85.00%)      13/20 (65.00%)    
Nervous system disorders     
temporarily hoarseness   13/20 (65.00%)  13 11/20 (55.00%)  11
temporarily dysphagia   10/20 (50.00%)  10 5/20 (25.00%)  5
cough   11/20 (55.00%)  11 1/20 (5.00%)  1
Horner syndrome   8/20 (40.00%)  8 4/20 (20.00%)  4
temporarily paresis of the hypoglossal nerve   7/20 (35.00%)  7 2/20 (10.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. med. Ronald Seidel
Organization: Helios Kliniken Schwerin
Phone: 0049 (0)385 5204251
Responsible Party: Dr.med.Ronald Seidel, Helios Research Center
ClinicalTrials.gov Identifier: NCT02336958     History of Changes
Other Study ID Numbers: A 2013-0075
First Submitted: January 2, 2015
First Posted: January 13, 2015
Results First Submitted: March 12, 2015
Results First Posted: March 23, 2015
Last Update Posted: March 23, 2015