Proximal Humeral FractureOptCCBNCT07612514
Optimized Costoclavicular Block for Elderly Proximal Humeral Fracture Surgery
A study testing Costoclavicular Brachial Plexus Block, Interscalene Brachial Plexus Block and Superficial Cervical Plexus Block in people with Proximal Humeral Fracture and Anesthesia, Regional, run by Shanghai Tong Ren Hospital at 3 sites in China.
Trial summary
Background: Proximal humeral fractures are common in elderly patients and often require surgical fixation (open reduction and internal fixation). Traditional regional anesthesia techniques, such as the interscalene brachial plexus block, may provide incomplete pain relief in the medial upper arm area and carry a high… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Proximal Humeral Fracture, Anesthesia, Regional, Diaphragmatic Paralysis
- What is being tested?
- Costoclavicular Brachial Plexus Block, Interscalene Brachial Plexus Block and Superficial Cervical Plexus Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesChina
- Study dates
- 1 Oct 2026to 1 Nov 2030
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Signed informed consent
- Age ≥65 years
- BMI <30
- American Society of Anesthesiologists (ASA) physical status I to III
- Unilateral proximal humeral fracture scheduled for open reduction and internal fixation via an anterior surgical approach (including deltopectoral approach and anteromedial deltoid approach)
Who cannot join
- Inability to perform T2 thoracic paravertebral block for any reason
- Coagulation dysfunction or current use of anticoagulant therapy
- History of upper extremity nerve injury or phrenic nerve injury
- Severe polytrauma
- Preoperative uncontrolled severe respiratory dysfunction (resting SpO2 <90% or home oxygen therapy, or FEV1 <30% of predicted value)
- Preoperative uncontrolled asthma, pulmonary infection, pneumothorax, or history of prior lung surgery
Show all 11Show fewer
- Preoperative uncontrolled hypertension with admission systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
- Preoperative uncontrolled coronary artery disease, valvular heart disease, or arrhythmia
- Any condition that precludes nerve block performance (e.g., local infection or swelling at the puncture site, inability to change position)
- Inability to communicate or cooperate with anesthesia administration (e.g., language barrier, intellectual disability, Alzheimer's disease, Parkinson's disease)
- Allergy to ropivacaine or any other contraindication to nerve block
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200336
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality
About this study
Official title: Effect of an Optimized Ultrasound-Guided Costoclavicular Brachial Plexus Block Strategy on Anesthetic Efficacy and Diaphragmatic Function in Elderly Patients Undergoing Internal Fixation of Proximal Humeral Fractures: A Multicenter, Prospective, Randomized Controlled Clinical Trial
Background: Proximal humeral fractures are common in elderly patients and often require surgical fixation (open reduction and internal fixation). Traditional regional anesthesia techniques, such as the interscalene brachial plexus block, may provide incomplete pain relief in the medial upper arm area and carry a high risk of hemidiaphragmatic paralysis, which can lead to breathing difficulties.
Objective: This study aims to evaluate whether an optimized nerve block strategy-ultrasound-guided costoclavicular brachial plexus block combined with superficial cervical plexus block and T2 thoracic paravertebral block-improves anesthetic success and reduces diaphragm dysfunction compared to the traditional interscalene approach in elderly patients undergoing proximal humeral fracture surgery.
Read more
Study Design: This is a multicenter, prospective, randomized, controlled, double-blind (participants and outcome assessors), superiority clinical trial.
Population: A total of 356 elderly patients (aged ≥65 years) with unilateral proximal humeral fractures scheduled for open reduction and internal fixation via an anterior surgical approach will be enrolled from three centers in Shanghai, China.
Intervention: Participants will be randomly assigned in a 1:1 ratio to one of two groups:
- Experimental Group (Optimized Strategy): Receives ultrasound-guided costoclavicular brachial plexus block + superficial cervical plexus block + T2 thoracic paravertebral block (0.375% ropivacaine 20 mL for brachial plexus, 0.25% ropivacaine 10 mL for each of the other blocks).
- Control Group (Traditional Strategy): Receives ultrasound-guided interscalene brachial plexus block + superficial cervical plexus block + T2 thoracic paravertebral block (same drug regimen).
All nerve blocks will be performed under ultrasound guidance by a single anesthesiologist. Patients and outcome assessors will be blinded to group assignment; the performing anesthesiologist cannot be blinded due to the distinct anatomical approaches.
Main Outcomes:
- Primary Outcome: Nerve block success rate, defined as no pain or only mild pain requiring no rescue analgesics (e.g., intravenous opioids, conversion to general anesthesia, or local infiltration) during surgery.
- Key Secondary Outcomes: Rate of hemidiaphragmatic paralysis (assessed by ultrasound M-mode); rate of conversion to general anesthesia; postoperative pain (NRS, 0-10) at 24 hours; perioperative stress biomarkers (cortisol, ACTH, IL-6, HMGB-1, CRP, galectin-3); and postoperative shoulder function recovery.
Safety Monitoring: Adverse events, including unplanned conversion to general anesthesia, respiratory depression, pneumothorax, and severe hemidiaphragmatic paralysis, will be recorded and managed according to predefined protocols. An independent Data Monitoring Committee will review safety data and conduct interim analyses for futility.
Study Duration: The study is expected to take approximately 24 months from first patient enrollment to final follow-up completion.
Ethical Approval: This study has been approved by the Ethics Committee of Shanghai Tongren Hospital. Approvals from the ethics committees of the other participating centers (Shanghai Sixth People's Hospital and Shanghai Xuhui Central Hospital) will be obtained before study initiation at those sites.
Read the detailed description
See brief summary.
- Being tested
- Costoclavicular Brachial Plexus Block, Interscalene Brachial Plexus Block, Superficial Cervical Plexus Block, T2 Thoracic Paravertebral Block
- Keywords
- Proximal Humeral Fracture, Elderly, Costoclavicular Block, Interscalene Block, Diaphragmatic Paralysis, Randomized Controlled Trial
- Medical subject headings
- Shoulder Fractures, Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Costoclavicular Brachial Plexus BlockProcedure or surgery
Ultrasound-guided brachial plexus block performed at the costoclavicular space. The patient is placed in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe is used to identify the brachial plexus at the costoclavicular space. Using an in-plane technique, 0.375% ropivacaine 20 mL is injected. This intervention is administered once prior to surgery.
Interscalene Brachial Plexus BlockProcedure or surgery
Ultrasound-guided brachial plexus block performed at the interscalene groove. The patient is placed in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe is used to identify the brachial plexus between the anterior and middle scalene muscles. Using an in-plane technique, 0.375% ropivacaine 20 mL is injected. This intervention is administered once prior to surgery.
Superficial Cervical Plexus BlockProcedure or surgery
Ultrasound-guided superficial cervical plexus block. The patient is placed in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe is used to identify the superficial cervical plexus at the lateral border of the sternocleidomastoid muscle. Using an in-plane technique, 0.25% ropivacaine 10 mL is injected. This intervention is administered once prior to surgery.
T2 Thoracic Paravertebral BlockProcedure or surgery
Ultrasound-guided T2 thoracic paravertebral block. The patient is placed in the lateral decubitus position with the operative side up. A low-frequency ultrasound probe is used to identify the T2 transverse process, rib, pleura, and costotransverse ligament. Using an in-plane technique, 0.25% ropivacaine 10 mL is injected. This intervention is administered once prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Costoclavicular Block Group | Experimental | Participants receive ultrasound-guided costoclavicular brachial plexus block (0.375% ropivacaine 20 mL) combined with superficial cervical plexus block (0.25% ropivacaine 10 mL) and T2 thoracic paravertebral block (0.25% ropivacaine 10 mL). Receives: Procedure: Costoclavicular Brachial Plexus Block; Procedure: Superficial Cervical Plexus Block; Procedure: T2 Thoracic Paravertebral Block |
| Interscalene Block Group | Active comparator | Ultrasound-guided interscalene brachial plexus block + superficial cervical plexus block + T2 thoracic paravertebral block. Ropivacaine: 0.375% 20 mL (brachial), 0.25% 10 mL (cervical + paravertebral). Receives: Procedure: Interscalene Brachial Plexus Block; Procedure: Superficial Cervical Plexus Block; Procedure: T2 Thoracic Paravertebral Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve Block Success Rate
Nerve block success is defined as no pain or only mild pain during surgery, with no need for rescue analgesics (including intravenous opioids, conversion to general anesthesia, or local infiltration). Block failure is defined as significant pain requiring any rescue analgesic measure to complete the surgery.
Measured: Intraoperative (assessed immediately after surgical incision and throughout the procedure)
Secondary outcomes (8)
Sensory Block in Four Regions
Sensory block is assessed using pinprick test at 20 minutes after nerve block completion in four regions: distal clavicular region, deltoid region, medial upper arm region, and lateral upper arm region. Grading: 0=no block (sharp pain), 1=partial block (reduced pain sensation), 2=complete block (no pain sensation).
Measured: 20 minutes after nerve block completion
Vasoactive Medication Requirements
Total intraoperative doses of vasoactive medications including urapidil, ephedrine, phenylephrine, and atropine.
Measured: Intraoperative
Rate of Hemidiaphragmatic Paralysis
Hemidiaphragmatic paralysis is assessed by ultrasound M-mode (sniff test). Complete paralysis: diaphragm excursion reduced by ≥75% from baseline or paradoxical movement. Partial paralysis: reduction of 25%-75%. No paralysis: reduction <25%.
Measured: 35 minutes after nerve block completion
Proportion of Surgeries Completed with Remifentanil Assistance
Proportion of patients who require intravenous remifentanil (0.25 μg/kg/min) to tolerate the surgery without conversion to general anesthesia.
Measured: Intraoperative
Conversion Rate to General Anesthesia
Proportion of patients requiring conversion to general anesthesia (laryngeal mask airway with sevoflurane) due to inadequate block despite remifentanil assistance.
Measured: Intraoperative
Postoperative Pain Score (NRS)
Pain intensity assessed using the Numeric Rating Scale (NRS, 0=no pain, 10=worst possible pain) at rest and during movement.
Measured: At 1, 2, 4, 6, 12, and 24 hours postoperatively
Perioperative Stress Biomarkers
Plasma concentrations of cortisol, ACTH, IL-6, HMGB-1, CRP, and galectin-3 measured by ELISA.
Measured: At four time points: preoperatively, 1 hour after surgery start, 30 minutes postoperatively, and 24 hours postoperatively
Incidence of Adverse Events
Adverse events include hypotension, hypertension, bradycardia, tachycardia, respiratory depression, pneumothorax, and severe hemidiaphragmatic paralysis requiring intervention.
Measured: Intraoperative and up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Nov 2030 (estimated)
Why it stopped: Due to a change in the study protocol and overall development strategy, the sponsor has decided to discontinue this trial and pursue an alternative study approach.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, stratified dynamic competition randomization (minimization randomization) with a 1:1 parallel assignment. An independent third-party statistical unit generates the randomization sequence and performs allocation concealment through a central randomization system. Stratification factors: study center, ASA grade (I-II vs III), COPD status, and Neer classification (2-part vs 3-4 part). After informed consent is obtained, a trained research nurse at each center submits the participant's baseline information via an encrypted central randomization system, which immediately returns a unique randomization number and group assignment. The allocation sequence is concealed from all researchers, anesthesiologists, and participants until unblinding at the end of the study. Patients, outcome assessors, and statisticians are blinded; the anesthesiologist performing the blocks cannot be blinded due to distinct anatomical approaches.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Tong Ren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 6th People's Hospital
- Responsible party
- Sponsor
- Investigators
- Junfeng Zhang, MD, Study chair, Shanghai Tong Ren HospitalWenyi Zhang, MMed, Principal investigator, Shanghai Tong Ren HospitalHui Zhang, MD, Principal investigator, Shanghai 6th People's HospitalZhen Zeng, MD, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612514
- Sponsor's protocol ID
- SHTR-2026-CCB-001
- Acronym
- OptCCB
- Status last verified
- Jul 2026
- First submitted
- 21 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sharing plan has not been finalized. Any decision regarding IPD sharing will be made in accordance with institutional policies, ethical approval, and participant confidentiality requirements.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Optimized Ultrasound-Guided Costoclavicular Brachial Plexus Block Strategy on Anesthetic Efficacy and Diaphragmatic Function in Elderly Patients Undergoing Internal Fixation of Proximal Humeral Fractures: A Multicenter, Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07612514
- Acronym / sponsor ID
- OptCCB / SHTR-2026-CCB-001
- Keywords
- Proximal Humeral Fracture, Elderly, Costoclavicular Block, Interscalene Block, Diaphragmatic Paralysis, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a change in the study protocol and overall development strategy, the sponsor has decided to discontinue this trial and pursue an alternative study approach.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Collaborators
- Shanghai 6th People's Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 28 May 2026 (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.
Background: Proximal humeral fractures are common in elderly patients and often require surgical fixation (open reduction and internal fixation). Traditional regional anesthesia techniques, such as the interscalene brachial plexus block, may provide incomplete pain relief in the medial upper arm area and carry a high risk of hemidiaphragmatic paralysis, which can lead to breathing difficulties.
Objective: This study aims to evaluate whether an optimized nerve block strategy-ultrasound-guided costoclavicular brachial plexus block combined with superficial cervical plexus block and T2 thoracic paravertebral block-improves anesthetic success and reduces diaphragm dysfunction compared to the traditional interscalene approach in elderly patients undergoing proximal humeral fracture surgery.
Study Design: This is a multicenter, prospective, randomized, controlled, double-blind (participants and outcome assessors), superiority clinical trial.
Population: A total of 356 elderly patients (aged ≥65 years) with unilateral proximal humeral fractures scheduled for open reduction and internal fixation via an anterior surgical approach will be enrolled from three centers in Shanghai, China.
Intervention: Participants will be randomly assigned in a 1:1 ratio to one of two groups:
- Experimental Group (Optimized Strategy): Receives ultrasound-guided costoclavicular brachial plexus block + superficial cervical plexus block + T2 thoracic paravertebral block (0.375% ropivacaine 20 mL for brachial plexus, 0.25% ropivacaine 10 mL for each of the other blocks).
- Control Group (Traditional Strategy): Receives ultrasound-guided interscalene brachial plexus block + superficial cervical plexus block + T2 thoracic paravertebral block (same drug regimen).
All nerve blocks will be performed under ultrasound guidance by a single anesthesiologist. Patients and outcome assessors will be blinded to group assignment; the performing anesthesiologist cannot be blinded due to the distinct anatomical approaches.
Main Outcomes:
- Primary Outcome: Nerve block success rate, defined as no pain or only mild pain requiring no rescue analgesics (e.g., intravenous opioids, conversion to general anesthesia, or local infiltration) during surgery.
- Key Secondary Outcomes: Rate of hemidiaphragmatic paralysis (assessed by ultrasound M-mode); rate of conversion to general anesthesia; postoperative pain (NRS, 0-10) at 24 hours; perioperative stress biomarkers (cortisol, ACTH, IL-6, HMGB-1, CRP, galectin-3); and postoperative shoulder function recovery.
Safety Monitoring: Adverse events, including unplanned conversion to general anesthesia, respiratory depression, pneumothorax, and severe hemidiaphragmatic paralysis, will be recorded and managed according to predefined protocols. An independent Data Monitoring Committee will review safety data and conduct interim analyses for futility.
Study Duration: The study is expected to take approximately 24 months from first patient enrollment to final follow-up completion.
Ethical Approval: This study has been approved by the Ethics Committee of Shanghai Tongren Hospital. Approvals from the ethics committees of the other participating centers (Shanghai Sixth People's Hospital and Shanghai Xuhui Central Hospital) will be obtained before study initiation at those sites.
Detailed description
See brief summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, stratified dynamic competition randomization (minimization randomization) with a 1:1 parallel assignment. An independent third-party statistical unit generates the randomization sequence and performs allocation concealment through a central randomization system. Stratification factors: study center, ASA grade (I-II vs III), COPD status, and Neer classification (2-part vs 3-4 part). After informed consent is obtained, a trained research nurse at each center submits the participant's baseline information via an encrypted central randomization system, which immediately returns a unique randomization number and group assignment. The allocation sequence is concealed from all researchers, anesthesiologists, and participants until unblinding at the end of the study. Patients, outcome assessors, and statisticians are blinded; the anesthesiologist performing the blocks cannot be blinded due to distinct anatomical approaches.
| Arm | Type | Receives |
|---|---|---|
| Costoclavicular Block Group | Experimental | Procedure: Costoclavicular Brachial Plexus Block, Procedure: Superficial Cervical Plexus Block, Procedure: T2 Thoracic Paravertebral BlockParticipants receive ultrasound-guided costoclavicular brachial plexus block (0.375% ropivacaine 20 mL) combined with superficial cervical plexus block (0.25% ropivacaine 10 mL) and T2 thoracic paravertebral block (0.25% ropivacaine 10 mL). |
| Interscalene Block Group | Active comparator | Procedure: Interscalene Brachial Plexus Block, Procedure: Superficial Cervical Plexus Block, Procedure: T2 Thoracic Paravertebral BlockUltrasound-guided interscalene brachial plexus block + superficial cervical plexus block + T2 thoracic paravertebral block. Ropivacaine: 0.375% 20 mL (brachial), 0.25% 10 mL (cervical + paravertebral). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Age ≥65 years
- BMI <30
- American Society of Anesthesiologists (ASA) physical status I to III
- Unilateral proximal humeral fracture scheduled for open reduction and internal fixation via an anterior surgical approach (including deltopectoral approach and anteromedial deltoid approach)
Key exclusion criteria (11 listed)
- Inability to perform T2 thoracic paravertebral block for any reason
- Coagulation dysfunction or current use of anticoagulant therapy
- History of upper extremity nerve injury or phrenic nerve injury
- Severe polytrauma
- Preoperative uncontrolled severe respiratory dysfunction (resting SpO2 <90% or home oxygen therapy, or FEV1 <30% of predicted value)
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 |
|---|---|---|
| Costoclavicular Brachial Plexus BlockUltrasound-guided brachial plexus block performed at the costoclavicular space. The patient is placed in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe is used to identify the brachial plexus at the costoclavicular space. Using an in-plane technique, 0.375% ropivacaine 20 mL is injected. This intervention is administered once prior to surgery. | Procedure or surgery | Costoclavicular Block Group |
| Interscalene Brachial Plexus BlockUltrasound-guided brachial plexus block performed at the interscalene groove. The patient is placed in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe is used to identify the brachial plexus between the anterior and middle scalene muscles. Using an in-plane technique, 0.375% ropivacaine 20 mL is injected. This intervention is administered once prior to surgery. | Procedure or surgery | Interscalene Block Group |
| Superficial Cervical Plexus BlockUltrasound-guided superficial cervical plexus block. The patient is placed in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe is used to identify the superficial cervical plexus at the lateral border of the sternocleidomastoid muscle. Using an in-plane technique, 0.25% ropivacaine 10 mL is injected. This intervention is administered once prior to surgery. | Procedure or surgery | Costoclavicular Block Group, Interscalene Block Group |
| T2 Thoracic Paravertebral BlockUltrasound-guided T2 thoracic paravertebral block. The patient is placed in the lateral decubitus position with the operative side up. A low-frequency ultrasound probe is used to identify the T2 transverse process, rib, pleura, and costotransverse ligament. Using an in-plane technique, 0.25% ropivacaine 10 mL is injected. This intervention is administered once prior to surgery. | Procedure or surgery | Costoclavicular Block Group, Interscalene Block Group |
Primary outcome
Nerve Block Success Rate
Time frame: Intraoperative (assessed immediately after surgical incision and throughout the procedure)
Nerve block success is defined as no pain or only mild pain during surgery, with no need for rescue analgesics (including intravenous opioids, conversion to general anesthesia, or local infiltration). Block failure is defined as significant pain requiring any rescue analgesic measure to complete the surgery.
8 secondary outcomes
Sensory Block in Four Regions
Time frame: 20 minutes after nerve block completion
Vasoactive Medication Requirements
Time frame: Intraoperative
Rate of Hemidiaphragmatic Paralysis
Time frame: 35 minutes after nerve block completion
Proportion of Surgeries Completed with Remifentanil Assistance
Time frame: Intraoperative
Conversion Rate to General Anesthesia
Time frame: Intraoperative
Postoperative Pain Score (NRS)
Time frame: At 1, 2, 4, 6, 12, and 24 hours postoperatively
Perioperative Stress Biomarkers
Time frame: At four time points: preoperatively, 1 hour after surgery start, 30 minutes postoperatively, and 24 hours postoperatively
Incidence of Adverse Events
Time frame: Intraoperative and up to 24 hours postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided. The data sharing plan has not been finalized. Any decision regarding IPD sharing will be made in accordance with institutional policies, ethical approval, and participant confidentiality requirements.
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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.
Junfeng Zhang, MD study chair
Shanghai Tong Ren Hospital
Wenyi Zhang, MMed principal investigator
Shanghai Tong Ren Hospital
Hui Zhang, MD principal investigator
Shanghai 6th People's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Costoclavicular Brachial Plexus Block, Interscalene Brachial Plexus Block and Superficial Cervical Plexus Block in people with Proximal Humeral Fracture and Anesthesia, Regional, run by Shanghai Tong Ren Hospital at 3 sites 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 11 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: withdrawn, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Nerve Block Success Rate (time frame: Intraoperative (assessed immediately after surgical incision and throughout the procedure)). 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 Jul 2026.