Minimum Effective Volume of Ropivacaine 7.5 mg/ml for the Lateral and Sagittal Infraclavicular Brachial Plexus Block
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Ropivacaine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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. |
- 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). [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | February 2012 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
-
Drug: Ropivacaine
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Norway | |
| University Hospital of North Norway | |
| Tromsø, Troms, Norway, 9038 | |
| Principal Investigator: | Lars M Ytrebo, Professor | University Hospital of North Norway |
More Information
No publications provided
| Responsible Party: | Lars Marius Ytrebo, Professor, University Hospital of North Norway |
| ClinicalTrials.gov Identifier: | NCT01493986 History of Changes |
| Other Study ID Numbers: | UNorthNorway |
| Study First Received: | December 14, 2011 |
| Last Updated: | September 9, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by University Hospital of North Norway:
|
Ropivacaine Brachial plexus |
Additional relevant MeSH terms:
|
Ropivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 13, 2013