- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03928574
USG Block of Cutaneous Nerves of the Arm
April 25, 2019 updated by: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Ultrasound-Guided Plane Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves:A Retrospective Observational Study
For superficial surgery of anteromedial and posteromedial surfaces of the upper arm, the medial brachial cutaneous nerve (MBCN) and the intercostobrachial nerve (ICBN) must be selectively blocked, in addition to an axillary brachial plexus block.
We compared efficacy of ultrasound-guided (USG) versus conventional block of the MBCN and the ICBN.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The primary objective of our study was to compare the effectiveness of conventional and USG blocks of the MBCN and the ICBN in the axillary fossa.
Our hypothesis was that the proportion of patients with complete anesthesia in the entire posteromedial and anteromedial surface of the arm would be greater if a USG technique were used, compared with a conventional technique.
The secondary objectives were onset time of complete anesthesia, volume of local anesthetic used for the procedure, tourniquet tolerance during surgery, and ultrasound visibility of MBCN and ICBN.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruizhao Lv, M.D
- Phone Number: +86-17772657375
- Email: lvruizhao@hotmail.com
Study Locations
-
-
Hebei
-
Cangzhou, Hebei, China, 061001
- Recruiting
- Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
-
Contact:
- Ruizhao Lv, M.D
- Phone Number: +86-17772657375
- Email: lvruizhao@hotmail.com
-
-
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
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
200
Description
Inclusion Criteria:
- Surgery of the distal upper limb : hand, forearm, lower third of the arm ,including the elbow
- Urgent or planned surgery
- Locoregional anesthesia : axillary brachial plexus block, completed by a medial brachial cutaneous nerve block and an intercostobrachial nerve block
Exclusion Criteria:
- Refused to sign informed consent
- Pregnant women
- Allergic to the local anesthetic
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ultrasound-Guided
Ultrasound-Guided Plane Block
|
Ultrasound-Guided Plane Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
|
Conventional
Conventional Block
|
Conventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with complete anesthesia
Time Frame: At time 20 minutes after the medial brachial cutaneous nerve and the intercostobrachial nerve block
|
Number of participants with complete anesthesia of the arm in region innervated by the MBCN and the ICBN
|
At time 20 minutes after the medial brachial cutaneous nerve and the intercostobrachial nerve block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia
Time Frame: At times 5, 10, 15, 20 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia at times 5, 10, 15, 20 minutes (except primary outcome) in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve
|
At times 5, 10, 15, 20 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Volume of local anesthetic
Time Frame: After nerve block immediately
|
The volume (in milliliters) of 1% lidocaine used for the medial brachial cutaneous nerve and the intercostobrachial nerve block
|
After nerve block immediately
|
Tourniquet tolerance
Time Frame: 3 hours after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Number of patients with comfortable feeling, with unpleasant sensations and with pains during surgery, in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve
|
3 hours after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Good ultrasound view of theses nerves before and after the injection of the local anesthetic
Time Frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Number of participants (of the ultrasound-guided group) with good ultrasound view of theses nerves before and after the injection of the local anesthetic
|
5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Bad ultrasound view of theses nerves before the injection and good ultrasound view of theses nerves after the injection of the local anesthetic
Time Frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Number of participants (of the ultrasound-guided group) with bad ultrasound view of theses nerves before the injection and good ultrasound view of theses nerves after the injection of the local anesthetic
|
5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Bad ultrasound view of theses nerves before and after the injection of the local anesthetic
Time Frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Number of participants (of the ultrasound-guided group) with bad ultrasound view of theses nerves before and after the injection of the local anesthetic
|
5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ruizha Lv, M.D, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
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)
April 1, 2019
Primary Completion (ANTICIPATED)
May 1, 2021
Study Completion (ANTICIPATED)
July 1, 2021
Study Registration Dates
First Submitted
May 8, 2018
First Submitted That Met QC Criteria
April 25, 2019
First Posted (ACTUAL)
April 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 25, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2019CZTCWM1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
Clinical Trials on Nerve Block
-
Lawson Health Research InstituteUnknownInferior Alveolar Nerve Block | Greater Palatine Nerve BlockCanada
-
Diskapi Teaching and Research HospitalCompletedArthroscopic Shoulder Surgery | Suprascapular Nerve Block | Axillary Nerve BlockTurkey
-
Tanta UniversityRecruitingArthroscopic Shoulder Surgery | Anterior Suprascapular Nerve Block | Interscalene Nerve BlockEgypt
-
Bozyaka Training and Research HospitalCompletedPeripheral Nerve Block | Foot and Ankle Surgery | Popliteal Nerve BlockTurkey
-
Charite University, Berlin, GermanySuspendedAnesthesia, Local | Brachial Plexus Block | Nerve BlockGermany
-
Zagazig UniversityCompletedPericapsular Nerve Group Block (PENG Block) | Lumbar Erector Spinae Plane BlockEgypt
-
University Hospital, AntwerpCompletedSurgery | Anesthesia | Brachial Plexus Block | Nerve BlockBelgium
-
Menoufia UniversityCompletedPericapsular Nerve Group Block (PENG Block) | Lumbar Erector Spinae Plane BlockEgypt
-
Ondokuz Mayıs UniversityCompletedAnesthesia, Local | Brachial Plexus Block | Nerve BlockTurkey
-
Peking Union Medical College HospitalNot yet recruiting
Clinical Trials on Ultrasound-Guided Plane Block
-
Assiut UniversityUnknownPain, Postoperative | Pulmonary Atelectasis | MastectomyEgypt
-
Mater Misericordiae University HospitalUnknown
-
Liu DiRecruitingLiver Neoplasms | Serratus Anterior Plane Block | Postoperative AnalgesiaChina
-
Tanta UniversityRecruiting
-
Tribhuvan University Teaching Hospital, Institute...Not yet recruiting
-
Nordsjaellands HospitalCompletedPostoperative PainDenmark
-
Tanta UniversityUnknownConventional Caudal Block | Ultrasound Guided Caudal Block | Ultrasound Guided Erector Spinae Block | Pediatric Hip SurgeryEgypt
-
Ain Shams UniversityCompleted
-
Zagazig UniversityCompletedPost-operative AnalgesiaEgypt
-
Tanta UniversityNot yet recruitingPain, Acute | Pain, Chronic | Erector Spinae Plane Block | Thoracic Interfascial Plane Block | Mastectomy, Modified Radical