NCT02336958

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 23, 2015

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

January 2, 2015

Results QC Date

March 12, 2015

Last Update Submit

March 12, 2015

Conditions

Carotid Stenosis

Keywords

cervical plexusregional anesthesiaultrasoundcarotid surgery

Outcome Measures

Primary Outcomes (2)

  • Number of Patients With Required Supplementation of Local Anesthetic by Surgeon

    during the intraoperative period

  • Amount (ml) of Local Anesthetic Supplemented by Surgeon

    during the intraoperative period

Study Arms (2)

ropivacaine

ACTIVE COMPARATOR

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.

Drug: intermediate cervical plexus block ropivacaineDrug: pericarotidal infiltration (active comparator) ropivacaineDrug: jugular infiltration prilocaine

saline

PLACEBO COMPARATOR

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.

Drug: intermediate cervical plexus block ropivacaineDrug: jugular infiltration prilocaineDrug: pericarotidal infiltration (placebo comparator) saline

Interventions

intermediate cervical plexus block ropivacaineDRUG

20ml ultrasound guided intermediate cervical plexus block.

ropivacainesaline
pericarotidal infiltration (active comparator) ropivacaineDRUG

5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.

ropivacaine
jugular infiltration prilocaineDRUG

5ml prilocaine 1% jugular infiltration for wound drainage.

ropivacainesaline
pericarotidal infiltration (placebo comparator) salineDRUG

5ml saline 0.9% (placebo comparator): pericarotidal infiltration.

saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • carotid surgery (symptomatic and asymptomatic carotid stenosis)
  • adult patients (18 years or older)
  • ASA-risk-groups I-IV
  • informed consent

You may not qualify if:

  • drug allergy: local anesthetics
  • pregnancy, lactation period
  • participation in other studies
  • addiction to drugs or alcohol
  • non-cooperative patients
  • no approval to regional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carotid Stenosis

Interventions

RopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr. med. Ronald Seidel
Organization
Helios Kliniken Schwerin
ronald.seidel@helios-kliniken.de
0049 (0)385 5204251

Study Officials

  • Ronald Seidel, Dr.med.

    Helios Kliniken Schwerin, Klinik für Anästhesiologie und Intensivtherapie, Wismarsche Strasse 393-7, 19049 Schwerin, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 2, 2015

First Posted

January 13, 2015

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 23, 2015

Results First Posted

March 23, 2015

Record last verified: 2015-03