- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02512471
The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
February 18, 2016 updated by: Fang Gang, Huazhong University of Science and Technology
The aim of this study is to determine the minimum effective volume of local anesthetic (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEV90) in young group (18-40 years) and in middle aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the shoulder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study is based on biased coin design, and the volume of LA for the next patient is determined by the result of the last one.
In the case of block failure, the volume will be increased by 2ml.
Conversely, block success will result in either a reduction in volume by 2ml (probability 11%) or no change in volume (probability 89%).
A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous nerves) at 10-min intervals up to 30 min after completion of the block.
Finally, MEV90 is calculated by isotonic regression.
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
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
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age between 18 and 65 years
- ASA 1-3
- body mass index between 18 and 35kg/m2
Exclusion Criteria:
- inability to consent to the study
- pregnancy
- allergy to local anesthetics
- preexisting neuropathy or coagulopathy
- prior surgery in the supraclavicular region
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: middle aged group
brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB
|
brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB (young group) brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB (middle-aged group)
Other Names:
|
Active Comparator: young group
brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB
|
brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB (young group) brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB (middle-aged group)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
Time Frame: up to 6 months
|
The Minimum Effective Volume (MEV) of Ropivacaine in Ultrasound-guided Supraclavicular Block is based on 55 measurements in 55 patients (secondary outcome measure: block success).
MEV is determined by biased coin design method when all patients have been tested in the study.
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ailin Luo, MD.,PhD, Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
May 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
July 25, 2015
First Submitted That Met QC Criteria
July 30, 2015
First Posted (Estimate)
July 31, 2015
Study Record Updates
Last Update Posted (Estimate)
February 19, 2016
Last Update Submitted That Met QC Criteria
February 18, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-64-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
Clinical Trials on Supraclavicular Brachial Plexus Block
-
Minia UniversityCompletedSupraclavicular Brachial Plexus BlockEgypt
-
Eslam Ayman Mohamed ShawkiUnknownSupraclavicular Brachial Plexus Block | DexamethasoneEgypt
-
Sohag UniversityNot yet recruiting
-
Zaher NazzalRecruitingSupraclavicular Brachial Plexus BlockPalestinian Territory, occupied
-
Tongji HospitalCompletedSupraclavicular Brachial Plexus BlockChina
-
Kafrelsheikh UniversityCompletedDexmedetomidine | Supraclavicular Brachial Plexus Block | BupivacaineEgypt
-
Diskapi Yildirim Beyazit Education and Research...CompletedBrachial Plexus BlockTurkey
-
University of MalayaCompletedBrachial Plexus Block
-
B.P. Koirala Institute of Health SciencesCompleted
-
University Hospital, AntwerpCompletedSurgery | Anesthesia | Brachial Plexus Block | Nerve BlockBelgium
Clinical Trials on Ropivacaine
-
Ziekenhuis Oost-LimburgNot yet recruitingAnesthesia | Hallux Valgus
-
University Health Network, TorontoUnknownPIB Versus CI Through a Popliteal Sciatic Nerve Catheter for Analgesia Following Major Ankle SurgeryPain, PostoperativeCanada
-
Northwestern UniversityCompletedPostoperative PainUnited States
-
Hospices Civils de LyonCompleted
-
Pusan National University HospitalCompletedHemodynamics | Epidural Anesthesia | Ropivacaine ConcentrationKorea, Republic of
-
Northwestern UniversityCompletedObesity | Postoperative Pain | PregnancyUnited States
-
Universiteit AntwerpenCompleted
-
San Gerardo HospitalIRCCS Policlinico S. Matteo; University of Milano Bicocca; Azienda L'ULSS 15... and other collaboratorsCompletedLaparoscopic CholecystectomyItaly
-
China Medical University, ChinaWithdrawn
-
China Medical University, ChinaCompleted