Intermediate Cervical Plexus Block for Carotid Endarterectomy Clinical Trial
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
| Verified date | March 2014 |
| Source | Salzburger Landeskliniken |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Agency for Health and Food Safety |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | December 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Klinik für Anästhesiologie, perioperative Medizin und allgemeine Intensivmedizin | Salzburg |
| Lead Sponsor | Collaborator |
|---|---|
| Salzburger Landeskliniken |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | amount of additional needed local anesthetics by the surgeon | 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. | 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. | No |
| Secondary | plasma concentrations of ropivacaine | measured with mass spectrometry | until 8h postoperative | No |
| Secondary | vital signs | continuous recording of vital signs during the surgery as well as in the postoperative ICU | whole day of surgery | No |
| Secondary | effect on the diaphragm function | assessment of phrenic nerve paresis by ultrasound measurement of the diaphragm excursions, performed by the radiologist on call | until 6 h postoperative | No |