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Completed

NCT Number: NCT01759940

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinik für Anästhesiologie, perioperative Medizin und allgemeine Intensivmedizin

Salzburg, State of Salzburg, 5020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ropivacaine 0,375%

Drug

ropivacaine 0,75%

Drug

Primary outcomes

  1. 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.

    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 outcomes

  1. plasma concentrations of ropivacaine

    Time frame: until 8h postoperative

    measured with mass spectrometry

  2. vital signs

    Time frame: whole day of surgery

    continuous recording of vital signs during the surgery as well as in the postoperative ICU

  3. effect on the diaphragm function

    Time frame: until 6 h postoperative

    assessment of phrenic nerve paresis by ultrasound measurement of the diaphragm excursions, performed by the radiologist on call

Sponsors and collaborators

Lead sponsor

Salzburger Landeskliniken

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 3, 2013
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.