Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01759940
Enrollment
46
Registered
2013-01-03
Start date
2012-11-30
Completion date
2013-12-31
Last updated
2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermediate Cervical Plexus Block for Carotid Endarterectomy

Keywords

carotid, endarterectomy, cervical block

Brief summary

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.

Interventions

DRUGropivacaine 0,375%

Sponsors

Salzburger Landeskliniken
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
amount of additional needed local anesthetics by the surgeonThe 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

MeasureTime frameDescription
vital signswhole day of surgerycontinuous recording of vital signs during the surgery as well as in the postoperative ICU
plasma concentrations of ropivacaineuntil 8h postoperativemeasured with mass spectrometry
effect on the diaphragm functionuntil 6 h postoperativeassessment of phrenic nerve paresis by ultrasound measurement of the diaphragm excursions, performed by the radiologist on call

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026