- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03329456
MEV to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus (LSIB)
January 28, 2019 updated by: University Hospital of North Norway
Minimum Effective Volume (MEV95%) of Ropivacaine 7.5 mg/ml to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus
The investigators have recently shown that LSIB in combination with a suprascapular and a cervical plexus block is a very good alternative for arthroscopic shoulder surgery.
However, the investigators believe the total volume of local anesthetic for LSIB may be reduced.
For shoulder surgery there is no need to block the medial cord and the investigators therefore hypothesize a significantly lower MEV95% by applying a selective lateral and posterior cord block
Study Overview
Detailed Description
The MEV for a successful block in 50% of the participants will be determined by using the staircase up-and-down method introduced by Dixon and Massey.
Logistic regression and probit transformation will be applied to estimate the MEV for a successful block in 95% of the participants.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Troms
-
Tromsø, Troms, Norway, 9038
- University Hospital of North Norway
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- . Inclusion criteria are American Society of Anesthesiologists (ASA) physical status I-III, age between 18 and 70 years and body mass index (BMI) between 20 and 35 kg/m2.
Exclusion Criteria:
- Exclusion criteria are pregnancy, patients with contraindications to regional anesthesia, allergy to LAs, patients taking opioids regularly due to chronic pain, use of anticoagulation drugs other than acetylsalicylic acid or dipyridamole, atrioventricular block, diabetes.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Ropivacaine
Single arm intervention
|
Minimum effective volume
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Minimum effective volume (95%)
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lars M Ytrebø, M.D Ph.D, University Hospital of North Norway
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Musso D, Flohr-Madsen S, Meknas K, Wilsgaard T, Ytrebo LM, Klaastad O. A novel combination of peripheral nerve blocks for arthroscopic shoulder surgery. Acta Anaesthesiol Scand. 2017 Oct;61(9):1192-1202. doi: 10.1111/aas.12948. Epub 2017 Aug 4.
- Musso D, Klaastad O, Wilsgaard T, Ytrebo LM. Brachial plexus block of the posterior and the lateral cord using ropivacaine 7.5 mg/mL. Acta Anaesthesiol Scand. 2019 Mar;63(3):389-395. doi: 10.1111/aas.13277. Epub 2018 Oct 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2017
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
October 30, 2017
First Submitted That Met QC Criteria
October 30, 2017
First Posted (Actual)
November 6, 2017
Study Record Updates
Last Update Posted (Actual)
January 29, 2019
Last Update Submitted That Met QC Criteria
January 28, 2019
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Musso
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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