Trial Outcomes & Findings for Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration (NCT NCT02336958)

NCT ID: NCT02336958

Last Updated: 2015-03-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: during the intraoperative period
• Results posted on: 2015-03-23

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration

Baseline characteristics by cohort

Measure	Ropivacaine n=20 Participants 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.	Saline n=20 Participants 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 n=40 Participants Total of all reporting groups
Age, Continuous	70.9 years STANDARD_DEVIATION 9.0 • n=5 Participants	72.2 years STANDARD_DEVIATION 7.7 • n=7 Participants	71.5 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: during the intraoperative period

Outcome measures

Measure	Ropivacaine n=20 Participants 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.	Saline n=20 Participants 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.
Number of Patients With Required Supplementation of Local Anesthetic by Surgeon	13 participants	13 participants

PRIMARY outcome

Timeframe: during the intraoperative period

Outcome measures

Measure	Ropivacaine n=20 Participants 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.	Saline n=20 Participants 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.
Amount (ml) of Local Anesthetic Supplemented by Surgeon	4.9 ml Interval 2.2 to 7.6	3.7 ml Interval 1.7 to 5.7

Adverse Events

Ropivacaine

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ropivacaine n=20 participants at risk 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.	Saline n=20 participants at risk 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.
Nervous system disorders definitive stroke	5.0% 1/20 • Number of events 1 • during the intraoperative period	0.00% 0/20 • during the intraoperative period

Other adverse events

Measure	Ropivacaine n=20 participants at risk 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.	Saline n=20 participants at risk 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.
Nervous system disorders temporarily hoarseness	65.0% 13/20 • Number of events 13 • during the intraoperative period	55.0% 11/20 • Number of events 11 • during the intraoperative period
Nervous system disorders temporarily dysphagia	50.0% 10/20 • Number of events 10 • during the intraoperative period	25.0% 5/20 • Number of events 5 • during the intraoperative period
Nervous system disorders cough	55.0% 11/20 • Number of events 11 • during the intraoperative period	5.0% 1/20 • Number of events 1 • during the intraoperative period
Nervous system disorders Horner syndrome	40.0% 8/20 • Number of events 8 • during the intraoperative period	20.0% 4/20 • Number of events 4 • during the intraoperative period
Nervous system disorders temporarily paresis of the hypoglossal nerve	35.0% 7/20 • Number of events 7 • during the intraoperative period	10.0% 2/20 • Number of events 2 • during the intraoperative period

Additional Information

Dr. med. Ronald Seidel

Helios Kliniken Schwerin

Phone: 0049 (0)385 5204251

Email: ronald.seidel@helios-kliniken.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place