Nerve BlockNCT03928574
USG Block of Cutaneous Nerves of the Arm
An observational study of Nerve Block, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Block
- What is being tested?
- Ultrasound-Guided Plane Block and Conventional Block
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200
Who may be able to join
- 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
Who cannot join
- Refused to sign informed consent
- Pregnant women
- Allergic to the local anesthetic
Trial locations and contacts
1 site in 1 country.
China1 site
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, 061001
About this study
Official title: 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.
Read the 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.
- Conditions
- Nerve Block
- Being tested
- Ultrasound-Guided Plane Block, Conventional Block
- Keywords
- Ultrasound-Guided Plane Block, Conventional Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Plane BlockProcedure or surgery
Ultrasound-Guided Plane Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
Conventional BlockProcedure or surgery
Conventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided | Ultrasound-Guided Plane Block Receives: Procedure: Ultrasound-Guided Plane Block | |
| Conventional | Conventional Block Receives: Procedure: Conventional Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complete anesthesia
Number of participants with complete anesthesia of the arm in region innervated by the MBCN and the ICBN
Measured: At time 20 minutes after the medial brachial cutaneous nerve and the intercostobrachial nerve block
Secondary outcomes (6)
Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia
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
Measured: 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
The volume (in milliliters) of 1% lidocaine used for the medial brachial cutaneous nerve and the intercostobrachial nerve block
Measured: After nerve block immediately
Tourniquet tolerance
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
Measured: 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
Number of participants (of the ultrasound-guided group) with good ultrasound view of theses nerves before and after the injection of the local anesthetic
Measured: 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
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
Measured: 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
Number of participants (of the ultrasound-guided group) with bad ultrasound view of theses nerves before and after the injection of the local anesthetic
Measured: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Apr 2019
- Primary completion1 May 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruizha Lv, M.D, Principal investigator, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928574
- Sponsor's protocol ID
- 2019CZTCWM1
- Status last verified
- Apr 2019
- First submitted
- 8 May 2018
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Plane Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves：A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT03928574
- Acronym / sponsor ID
- 2019CZTCWM1
- Conditions
- Nerve Block
- Keywords
- Ultrasound-Guided Plane Block, Conventional Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western MedicineUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided | – | Procedure: Ultrasound-Guided Plane BlockUltrasound-Guided Plane Block |
| Conventional | – | Procedure: Conventional BlockConventional Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Refused to sign informed consent
- Pregnant women
- Allergic to the local anesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Plane BlockUltrasound-Guided Plane Block Medial Brachial Cutaneous and the Intercostobrachial Nerves | Procedure or surgery | Ultrasound-Guided |
| Conventional BlockConventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves | Procedure or surgery | Conventional |
Primary outcome
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
6 secondary outcomes
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
Volume of local anesthetic
Time frame: 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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruizha Lv, M.D principal investigator
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve Block, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complete anesthesia (time frame: At time 20 minutes after the medial brachial cutaneous nerve and the intercostobrachial nerve block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.