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

NCT ID: NCT01759940

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-12-31

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.

Conditions

Intermediate Cervical Plexus Block for Carotid Endarterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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%.

Group Type: EXPERIMENTAL

ropivacaine 0,375%

Intervention Type: DRUG

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%.

Group Type: ACTIVE_COMPARATOR

ropivacaine 0,75%

Intervention Type: DRUG

Interventions

ropivacaine 0,375%

Intervention Type: DRUG

ropivacaine 0,75%

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salzburger Landeskliniken

OTHER

Sponsor Role: lead

Responsible Party

Andreas Kokoefer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Kokoefer, MD

Role: PRINCIPAL_INVESTIGATOR

Salk Institute for Biological Studies

Locations

Klinik für Anästhesiologie, perioperative Medizin und allgemeine Intensivmedizin

Salzburg, Salzburg, Austria

Countries

Austria

References

Kokofer A, Nawratil J, Felder TK, Stundner O, Mader N, Gerner P. Ropivacaine 0.375% vs. 0.75% with prilocaine for intermediate cervical plexus block for carotid endarterectomy: A randomised trial. Eur J Anaesthesiol. 2015 Nov;32(11):781-9. doi: 10.1097/EJA.0000000000000243.

Reference Type: DERIVED

PMID: 25782662 (View on PubMed)

Other Identifiers

2012-002769-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

cervicalblock

Identifier Type: -

Identifier Source: org_study_id