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Hand and Forearm TraumaNCT07326943

Minimum Effective Dose of Ropivacaine for Ultrasound-guided Interscalene Block

A study testing Ultrasound guided intermuscular groove block targeting the C7 nerve root in people with Hand and Forearm Trauma and Hand and Forearm Diseases, run by Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Inter muscular groove brachial plexus block is a commonly used peripheral nerve block technique in clinical practice, commonly used for anesthesia and analgesia in clavicle, shoulder, and humeral surgeries. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Ultrasound guided intermuscular groove block targeting the C7 nerve root
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
1 May 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age range: 18-60 years old
  • ASAⅠ~II
  • BMI between 18 and 30kg/m2
  • Patients undergoing hand or forearm surgery
  • Sign informed consent form

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huailiang LI, contact

86+18834183517

574199674@qq.com

Zheng Hua, Study Principal Investigator contact

86+18672750530

China1 site, 1 recruiting
  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

    Xiaomin zhang, 8618435148730, sxdyyky@126.com

    Recruiting

Other trials in China

About this study

Official title: Minimum Effective Dose of Ropivacaine 0.5% for Ultrasound-guided Interscalene Block Targeting the C7 Nerve Root in Hand and Forearm Surgery

Inter muscular groove brachial plexus block is a commonly used peripheral nerve block technique in clinical practice, commonly used for anesthesia and analgesia in clavicle, shoulder, and humeral surgeries. The classic ultrasound-guided intermuscular groove block also involves puncturing the needle to the level of the C5/C6 anterior branch for drug injection. After injection, local anesthetics mainly wrap around C5, C6, and some C7 nerve roots. Therefore, intermuscular groove block is mainly used for shoulder, humerus, and clavicle surgery. Due to incomplete ulnar block, it is not recommended for surgery on the elbow joint and its distal end.Scholars have found that using C5 as the puncture target to implement intermuscular groove block and administering 10ml of 0.75% ropivacaine, the success rate of ulnar nerve block is 19%. The success rate of ulnar nerve block with C6 as the puncture target was 93% when 10ml of 0.75% ropivacaine was administered. This suggests that blockade methods closer to the tail muscle groove on the tail side have a higher success rate for blocking the C7, C8, and T1 nerve roots. In our clinical work, the investigators found that when performing intermuscular groove block with C7 nerve root as the puncture target, local anesthetics not only stably wrap around C7 nerve root, but also spread to wrap around C5 and C6 nerve roots on the head side, and spread to the deep surface of the brachial plexus trunk on the tail side. Local anesthetic diffusion can also be seen in some patients at the brachial plexus bundle in the intercostal space. From the perspective of local anesthetic diffusion patterns, intermuscular groove block targeting the C7 nerve root may cover the anterior branches of C5, C6, C7, C8, and T1 nerve roots, achieving complete brachial plexus block. Preliminary clinical practice suggests that C7 intermuscular groove block can be used for forearm and hand surgery. Successful C7 intermuscular groove block relies on the diffusion and wrapping of local anesthetics around the anterior branches of C5, C6, and C7 nerve roots, as well as the inferior trunk of the brachial plexus (or the anterior branches of C8 and T1 nerve roots).Therefore, the investigators designed this study to determine the amount of local anesthetic required to achieve stable forearm and hand block during C7 intermuscular groove block.

Read the detailed description

Inter muscular groove brachial plexus block is a commonly used peripheral nerve block technique in clinical practice, commonly used for anesthesia and analgesia in clavicle, shoulder, and humeral surgeries. Intermuscular groove block is achieved by injecting local anesthetics between the anterior and middle scalene muscles in order to block the anterior branches of the cervical nerve that pass through this gap, including the anterior branches of the cervical 5 (C5), cervical 6 (C6), and cervical 7 (C7) spinal nerves. The classic technique of intermuscular groove block involves puncturing the thyroid cartilage horizontally into the intermuscular groove. This area is roughly equivalent to the level of the anterior branch of the C5/C6 nerve root. The classic ultrasound-guided intermuscular groove block also involves puncturing the needle to the level of the C5/C6 anterior branch for drug injection. After injection, local anesthetics mainly wrap around C5, C6, and some C7 nerve roots. According to the range of spinal nerve innervation, its blocking range is located in the shoulder, the anterior, posterior, and lateral sides of the upper arm, the anterior, posterior, and lateral sides of the forearm, and the two and a half fingers on the radial side. Therefore, intermuscular groove block is mainly used for shoulder, humerus, and clavicle surgery. Due to incomplete ulnar block, it is not recommended for surgery on the elbow joint and its distal end.Scholars have found that using C5 as the puncture target to implement intermuscular groove block and administering 10ml of 0.75% ropivacaine, the success rate of ulnar nerve block is 19%. The success rate of ulnar nerve block with C6 as the puncture target was 93% when 10ml of 0.75% ropivacaine was administered. This suggests that blockade methods closer to the tail muscle groove on the tail side have a higher success rate for blocking the C7, C8, and T1 nerve roots. In our clinical work, the investigators found that when performing intermuscular groove block with C7 nerve root as the puncture target, local anesthetics not only stably wrap around C7 nerve root, but also spread to wrap around C5 and C6 nerve roots on the head side, and spread to the deep surface of the brachial plexus trunk on the tail side. Local anesthetic diffusion can also be seen in some patients at the brachial plexus bundle in the intercostal space. From the perspective of local anesthetic diffusion patterns, intermuscular groove block targeting the C7 nerve root may cover the anterior branches of C5, C6, C7, C8, and T1 nerve roots, achieving complete brachial plexus block. In the preliminary exploratory clinical work, the patient underwent C7 nerve root intermuscular groove brachial plexus block. Through sensory testing, it was found that the musculocutaneous nerve, medial forearm nerve, radial nerve, median nerve, and ulnar nerve could all be stably blocked, and the forearm and hand surgeries were successfully completed under nerve block. Preliminary clinical practice suggests that C7 intermuscular groove block can be used for forearm and hand surgery. Successful C7 intermuscular groove block relies on the diffusion and wrapping of local anesthetics around the anterior branches of C5, C6, and C7 nerve roots, as well as the inferior trunk of the brachial plexus (or the anterior branches of C8 and T1 nerve roots).Therefore, the investigators designed this study to determine the amount of local anesthetic required to achieve stable forearm and hand block during C7 intermuscular groove block.

Being tested
Ultrasound guided intermuscular groove block targeting the C7 nerve root
Keywords
ultrasound-guided interscalene block, Minimum effective dose, C7 nerve root

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided intermuscular groove block targeting the C7 nerve rootProcedure or surgery

    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.

  • Ultrasound guided intermuscular groove block targeting the C7 nerve rootProcedure or surgery

    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.

Study groups in NCT07326943
Study groupRoleWhat they receive
DeceasingExperimentalBrachial plexus block with decreasing dose. Real time ultrasound-guided intermuscular brachial plexus block anesthesia targeting the C7 nerve root.
Receives: Procedure: Ultrasound guided intermuscular groove block targeting the C7 nerve root
similarExperimentalBrachial plexus block, with similar doses. Real time ultrasound-guided intermuscular brachial plexus block anesthesia for C7 nerve roots
Receives: Procedure: Ultrasound guided intermuscular groove block targeting the C7 nerve root

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of blocking effect

    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).

    Measured: From the completion of nerve block to the 30th minute after block

Secondary outcomes (1)
  1. Diaphragmatic muscle movement status

    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

    Measured: From the completion of nerve block to the 30th minute after block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start1 May 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This experiment enrolled participants using a biased coin up and down sequential method. The first subject was given 0.5% ropivacaine 12mL. The subsequent dose of ropivacaine for each subject depends on the anesthetic effect of the previous subject. If the effect of the previous subject is "failure" (negative reaction), the dose of ropivacaine will be increased by 1mL for the next subject. If the effect of the previous subject is "success" (positive reaction), the next subject will be randomized using the partial currency method. The patients will be randomly divided into two groups: one group will receive the same dose of ropivacaine as the previous subject (probability B=0.89) (same dose group); The dose of ropivacaine in another group decreased by 1mL (probability 1-B=0.11). The criterion for successful blockade is to simultaneously meet the following two criteria: (1) disappearance of sensory sensation in the muscle cutaneous nerve, medial forearm cutaneous nerve, median nerve, rad
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07326943
Sponsor's protocol ID
YXLL-2025-292
Status last verified
Sep 2026
First submitted
22 Dec 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Paper case report forms were written by hand

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided intermuscular groove block targeting the C7 nerve root in people with Hand and Forearm Trauma and Hand and Forearm Diseases, run by Huazhong University of Science and Technology 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huailiang LI, (86+18834183517, 574199674@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of blocking effect (time frame: From the completion of nerve block to the 30th minute after 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 17 Sep 2026.

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