Optimized Costoclavicular Block for Elderly Proximal Humeral Fracture Surgery (OptCCB)
7. juli 2026 opdateret af: Shanghai Tong Ren Hospital
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.
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.
Studieoversigt
Status
Trukket tilbage
Detaljeret beskrivelse
See brief summary.
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina
- Shanghai Sixth People's Hospital
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Shanghai, Shanghai Municipality, Kina
- Shanghai Xuhui Central Hospital
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Shanghai, Shanghai Municipality, Kina, 200336
- Shanghai Tongren Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Costoclavicular Block Group
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).
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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.
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.
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.
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Aktiv komparator: Interscalene Block Group
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).
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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.
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.
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Nerve Block Success Rate
Tidsramme: Intraoperative (assessed immediately after surgical incision and throughout the procedure)
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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.
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Intraoperative (assessed immediately after surgical incision and throughout the procedure)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sensory Block in Four Regions
Tidsramme: 20 minutes after nerve block completion
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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).
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20 minutes after nerve block completion
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Vasoactive Medication Requirements
Tidsramme: Intraoperative
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Total intraoperative doses of vasoactive medications including urapidil, ephedrine, phenylephrine, and atropine.
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Intraoperative
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Rate of Hemidiaphragmatic Paralysis
Tidsramme: 35 minutes after nerve block completion
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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%.
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35 minutes after nerve block completion
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Proportion of Surgeries Completed with Remifentanil Assistance
Tidsramme: Intraoperative
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Proportion of patients who require intravenous remifentanil (0.25 μg/kg/min) to tolerate the surgery without conversion to general anesthesia.
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Intraoperative
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Conversion Rate to General Anesthesia
Tidsramme: Intraoperative
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Proportion of patients requiring conversion to general anesthesia (laryngeal mask airway with sevoflurane) due to inadequate block despite remifentanil assistance.
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Intraoperative
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Postoperative Pain Score (NRS)
Tidsramme: At 1, 2, 4, 6, 12, and 24 hours postoperatively
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Pain intensity assessed using the Numeric Rating Scale (NRS, 0=no pain, 10=worst possible pain) at rest and during movement.
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At 1, 2, 4, 6, 12, and 24 hours postoperatively
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Perioperative Stress Biomarkers
Tidsramme: At four time points: preoperatively, 1 hour after surgery start, 30 minutes postoperatively, and 24 hours postoperatively
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Plasma concentrations of cortisol, ACTH, IL-6, HMGB-1, CRP, and galectin-3 measured by ELISA.
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At four time points: preoperatively, 1 hour after surgery start, 30 minutes postoperatively, and 24 hours postoperatively
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Incidence of Adverse Events
Tidsramme: Intraoperative and up to 24 hours postoperatively
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Adverse events include hypotension, hypertension, bradycardia, tachycardia, respiratory depression, pneumothorax, and severe hemidiaphragmatic paralysis requiring intervention.
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Intraoperative and up to 24 hours postoperatively
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Junfeng Zhang, MD, Shanghai Tong Ren Hospital
- Ledende efterforsker: Wenyi Zhang, MMed, Shanghai Tong Ren Hospital
- Ledende efterforsker: Hui Zhang, MD, Shanghai 6th People's Hospital
- Ledende efterforsker: Zhen Zeng, MD, Shanghai Xuhui Central Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. oktober 2029
Studieafslutning (Anslået)
1. november 2030
Datoer for studieregistrering
Først indsendt
21. maj 2026
Først indsendt, der opfyldte QC-kriterier
21. maj 2026
Først opslået (Faktiske)
28. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SHTR-2026-CCB-001
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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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