Influence of the Concentration of the Local Anesthetic Ropivacaine on the Quality of a Ultrasound Guided Intermediate Cervical Block.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreas Kokoefer, Salzburger Landeskliniken
ClinicalTrials.gov Identifier:
NCT01759940
First received: December 31, 2012
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

Carotid endarterectomy is commonly performed under cervical plexus block. This is presumed to offer advantages over general anesthesia in terms of monitoring neurological function during cross-clamping of the carotid artery since, in conscious patients, speech, cerebration, and motor power provide early measures of inadequate cerebral perfusion. Some studies also claim lower shunting requirements, lower cardiovascular morbidity, and shorter hospital stay.

Traditionally, the common methods of cervical plexus block are termed 'deep' or 'superficial'. The deep block, as described by Moore or Winnie and colleagues, consists of identifying the transverse processes of upper cervical vertebrae C2 - C4 and injecting local anesthetic directly into the deep (prevertebral) cervical space. This may be achieved either as separate injections or as a single injection. The superficial block incorporates a variety of procedures. The simplest is a s.c. infiltration of local anesthetic along the posterior border of sternocleidomastoid muscle by either the surgeon or the anesthetist.

An 'intermediate' block is one where the injecting needle pierces the investing fascia of the neck, deep to the s.c. layer, but superficial to the deep cervical (prevertebral) fascia. It is also possible to use a 'combined block', consisting of a deep injection and a superficial or intermediate injection.

Practitioners may prefer one block to another, but no consensus exists on the efficacy of one block when compared with another. However, it has been suggested that complications of the technique are related to the deep injection and not the superficial (or intermediate) injection. These complications include intrathecal or intravascular injection, respiratory problems related to phrenic nerve paralysis, or local anaesthetic toxicity.

In this study the Influence of the concentration of the local anesthetic ropivacaine on the quality of the intermediate cervical plexus block for carotid endarterectomy will be evaluated. For this purpose two different concentrations of ropivacaine will be compared (3,75% vs 7,5%). The primary endpoint of the study will be the quantity of the additional needed local anesthetic to achieve adequate operative analgesia. Furthermore we will record the frequency of the most common side effects as well as the patient satisfaction with a standardized questionnaire.


Condition Intervention Phase
Intermediate Cervical Plexus Block for Carotid Endarterectomy
Drug: ropivacaine 0,375%
Drug: ropivacaine 0,75%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of the Concentration of the Local Anesthetic Ropivacaine on the Quality of a Ultrasound Guided Block of the Regio Collis Lateralis for Carotid Endarterectomy: a Prospective, Randomized and Controlled Trail

Resource links provided by NLM:


Further study details as provided by Salzburger Landeskliniken:

Primary Outcome Measures:
  • amount of additional needed local anesthetics by the surgeon [ Time Frame: The primary endpoint will be evaluated continuously during the ongoing surgery by interrogating the patients pain scale every two to five minutes. In average the whole procedure will take 30 to 50 minutes. ] [ Designated as safety issue: No ]
    The surgeon will titrate the local anesthetic lidocaine 2%to achieve adequate operative analgesia for the patient. During the surgical procedure the patient will not be sedated therefore distinct communication to the patient is always possible.


Secondary Outcome Measures:
  • plasma concentrations of ropivacaine [ Time Frame: until 8h postoperative ] [ Designated as safety issue: No ]
    measured with mass spectrometry

  • vital signs [ Time Frame: whole day of surgery ] [ Designated as safety issue: No ]
    continuous recording of vital signs during the surgery as well as in the postoperative ICU

  • effect on the diaphragm function [ Time Frame: until 6 h postoperative ] [ Designated as safety issue: No ]
    assessment of phrenic nerve paresis by ultrasound measurement of the diaphragm excursions, performed by the radiologist on call


Enrollment: 46
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ropivacaine 0,375%
In the study group the intermediate cervical block will be performed by ultrasound guidance using 20ml ropivacaine 0,375%. Additionally 10ml prilocaine 1% will be used to infiltrate the perivascular tissue around the carotid artery. In the area of the expected incision the skin will also be infiltrated with 10ml prilocaine 1%.
Drug: ropivacaine 0,375%
Active Comparator: ropivacaine 0,75%
In the control group the intermediate cervical block will be performed by ultrasound guidance using 20ml ropivacaine 0,75%. Additionally 10ml prilocaine 1% will be used to infiltrate the perivascular tissue around the carotid artery. In the area of the expected incision the skin will also be infiltrated with 10ml prilocaine 1%.
Drug: ropivacaine 0,75%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for carotid endarterectomy in regional anesthesia

Exclusion Criteria:

  • refusal to participate in the trail
  • age < 18a
  • gestation/breastfeeding
  • contraindication for regional anesthesia
  • inclusion in other trails
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01759940

Locations
Austria
Klinik für Anästhesiologie, perioperative Medizin und allgemeine Intensivmedizin
Salzburg, Austria, 5020
Sponsors and Collaborators
Salzburger Landeskliniken
Investigators
Principal Investigator: Andreas Kokoefer, MD SALK
  More Information

No publications provided

Responsible Party: Andreas Kokoefer, MD, Salzburger Landeskliniken
ClinicalTrials.gov Identifier: NCT01759940     History of Changes
Other Study ID Numbers: cervicalblock, 2012-002769-37
Study First Received: December 31, 2012
Last Updated: March 15, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Salzburger Landeskliniken:
carotid
endarterectomy
cervical block

Additional relevant MeSH terms:
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014