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Minimum Effective Volume of Ropivacaine 7.5 mg/ml for the Lateral and Sagittal Infraclavicular Brachial Plexus Block

Minimum Effective Volume of Ropivacaine 7.5 mg/ml for the Lateral and Sagittal Infraclavicular Brachial Plexus Block When Using Guidance by Both Ultrasound and Nerve Stimulation.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01493986
Enrollment
25
Registered
2011-12-16
Start date
2012-02-29
Completion date
2012-07-31
Last updated
2012-09-11

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

Conditions

Pain

Keywords

Ropivacaine, Brachial plexus

Brief summary

Systemic LA toxicity is an important complication of regional anesthesia. Lowering the LA dose is one of the strategies to reduce this risk. For upper limb blocks it is well documented that ultrasound guidance allows a significant lower dose of LA for interscalene and axillary blocks than with guidance by peripheral nerve stimulation. However, a corresponding difference has not yet been found for supraclavicular and infraclavicular blocks. The aim of the present study is to define the minimum effective volume of ropivacaine 7.5 mg/ml when using the LSIB method.

Detailed description

The blocks will be performed as previously described, by an anesthesiologist with LSIB expertise. The lateral, medial and posterior cords are the target of infra-clavicular brachial plexus blocks. During a prescan we will record if they can be visualized by ultrasound and indicate their positions periarterially. The deep location of the cords may hamper their identification, especially that of the medial cord. We describe the cord positions with reference to the short-axis (cross-sectional) view of the axillary artery, which is compared to a clockface having 12 o'clock ventrally. In a former MRI study it was found that the cords were usually located in a sector from 3-11 o'clock (the 3-11 sector) and within a distance of 2 cm from the midaxis of the axillary artery. The point closest to the cords was at 8 o'clock, immediately outside the arterial wall. Point of needle insertion is at the intersection between the lower edge of the clavicle and the medial surface of the coracoid process. We direct the needle tip to the 8 o'clock position and observe the spread of LA from this position. On demand we adjust the needle position to secure a complete fill of the 3-11 sector with LA (multiple injections). The block needle has an electrical cable. Prior to LA injections we test if a minimal electric output (0.2 mA/0.1 msec duration) elicits a motor response. If such a response is obtained, the needle is withdrawn (in steps of 1 mm), until the motor response disappears. This is to reduce the risk of intraneural injection.

Interventions

DRUGRopivacaine

Dosage. Onset time

Sponsors

University Hospital of North Norway
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients of American Society of Anesthesiologists physical status (ASA) I-II * Scheduled for surgery distal to the elbow. * Duration of surgery \>1 hour. * Age 18-65 years, * Body mass index 20-35 kg/m2

Exclusion criteria

* Pregnancy * Any contraindication to regional anesthesia * Patients on major opioids because of chronic pain * Atrioventricular block * Pacemaker * Diabetes * Peripheral neuropathy

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the minimum effective volume of ropivacaine 7.5 mg/ml providing a successful infraclavicular block (LSIB) in 50% of the patients (MEAV50).30 minutes

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026