- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07326943
Minimum Effective Dose of Ropivacaine for Ultrasound-guided Interscalene Block
Minimum Effective Dose of Ropivacaine 0.5% for Ultrasound-guided Interscalene Block Targeting the C7 Nerve Root in Hand and Forearm Surgery
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huailiang LI,
- Phone Number: 86+18834183517
- Email: 574199674@qq.com
Study Contact Backup
- Name: Zheng Hua, Study Principal Investigator
- Phone Number: 86+18672750530
Study Locations
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030032
- Recruiting
- Shanxi Bethune Hospital
-
Contact:
- Xiaomin zhang
- Phone Number: 8618435148730
- Email: sxdyyky@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age range: 18-60 years old
- ASAⅠ~II
- BMI between 18 and 30kg/m2
- Patients undergoing hand or forearm surgery
- Sign informed consent form
Exclusion Criteria:
- Refusal to participate in the experiment
- Merge peripheral nerve diseases
- Lidocaine and ropivacaine allergy
- Pregnant women
- Obstructive or restrictive lung disease
- Coagulation dysfunction
- Long term use of opioid drugs
- Infection, tumor or surgical history at the puncture site
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Deceasing
Brachial plexus block with decreasing dose.
Real time ultrasound-guided intermuscular brachial plexus block anesthesia targeting the C7 nerve root.
|
The patient will receive ultrasound-guided intermuscular groove brachial plexus block targeting the C7 nerve root, decreasing doses of ropivacaine 0.5% will be administered.
The patient will receive ultrasound-guided intermuscular groove brachial plexus block targeting the C7 nerve root, similar doses of ropivacaine 0.5% will be administered.
|
|
Experimental: similar
Brachial plexus block, with similar doses.
Real time ultrasound-guided intermuscular brachial plexus block anesthesia for C7 nerve roots
|
The patient will receive ultrasound-guided intermuscular groove brachial plexus block targeting the C7 nerve root, decreasing doses of ropivacaine 0.5% will be administered.
The patient will receive ultrasound-guided intermuscular groove brachial plexus block targeting the C7 nerve root, similar doses of ropivacaine 0.5% will be administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of blocking effect
Time Frame: From the completion of nerve block to the 30th minute after block
|
Starting from the completion of the nerve block, an independent evaluator (unaware of the dosage used) will test and record the block effect at 10, 20, and 30 minutes after the block.
The block effect will be judged based on the effect at 30 minutes.
Conduct sensory tests on the skin innervated by various nerves using ice cubes.
Use a 3-point numerical scale (0=normal cold sensation, no obstruction; 1=partial cold sensation, partial obstruction; 2=no cold sensation, complete obstruction).
Radial nerve, median nerve, ulnar nerve, musculocutaneous nerve, and medial forearm cutaneous nerve.
Evaluate the degree of motor block through specific exercise activities (0=normal activity, 1=partial block, 2=complete block).
Patients who are fully awake or have been administered an appropriate amount of sedatives, maintain spontaneous breathing, and successfully complete the surgery are considered to have successful blockade (i.e.
positive reaction).
|
From the completion of nerve block to the 30th minute after block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragmatic muscle movement status
Time Frame: From the completion of nerve block to the 30th minute after block
|
Ultrasound measurement of basal range of motion of the blocked ipsilateral diaphragm: The patient is seated in a semi seated position, with a low-frequency convex array probe placed between the anterior axillary line and the midline of the axilla. Real time M-mode ultrasound is used to evaluate the motion of the ipsilateral diaphragm. Use a low intercostal or subcostal approach, with the liver or spleen as the sound window for scanning. Record the diaphragm movement amplitude during rapid nasal inhalation from the resting exhalation position. Measure three times and take the average. And retain the measured images. 30 minutes after the completion of nerve block, evaluate the patient's diaphragm movement using the same method as before. The degree of diaphragmatic block is defined as a decrease in movement amplitude of>75% (complete diaphragmatic block), a decrease in movement amplitude of 25-75% (partial block), and a decrease of<25% (no block) compared to before the block was impleme |
From the completion of nerve block to the 30th minute after block
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications of nerve block
Time Frame: From the completion of nerve block to the 30th minute after block
|
The evaluator also records the occurrence of complications such as hypersensitivity, vascular injury, recurrent laryngeal nerve block, Horner's syndrome, and local anesthetic poisoning during the blocking process.
|
From the completion of nerve block to the 30th minute after block
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- YXLL-2025-292
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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