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

Phase 4

Completed

• Conditions: Intermediate Cervical Plexus Block for Carotid Endarterectomy
• Interventions: Drug: ropivacaine 0,375%; Drug: ropivacaine 0,75%

• Registration Number: NCT01759940
• Lead Sponsor: Salzburger Landeskliniken

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-31
• Study First Submitted QC: 2012-12-31
• Study First Posted: 2013-01-03
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-15
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine 0,375%	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%.
ropivacaine 0,75%	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%.

Primary Outcome Measures

Name	Time	Method
amount of additional needed local anesthetics by the surgeon	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 Outcome Measures

Name	Time	Method
plasma concentrations of ropivacaine	until 8h postoperative	measured with mass spectrometry
vital signs	whole day of surgery	continuous recording of vital signs during the surgery as well as in the postoperative ICU
effect on the diaphragm function	until 6 h postoperative	assessment of phrenic nerve paresis by ultrasound measurement of the diaphragm excursions, performed by the radiologist on call

Trial Locations

Locations (1)

Klinik für Anästhesiologie, perioperative Medizin und allgemeine Intensivmedizin; 🇦🇹 Salzburg, Austria