Optimized Costoclavicular Block for Elderly Proximal Humeral Fracture Surgery (OptCCB)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Proximal Humeral Fracture; Anesthesia, Regional; Diaphragmatic Paralysis
• Intervention / Treatment: Procedure: Costoclavicular Brachial Plexus Block; Procedure: Superficial Cervical Plexus Block; Procedure: T2 Thoracic Paravertebral Block; Procedure: Interscalene Brachial Plexus Block

Detailed Description

See brief summary.

• Study Type: Interventional
• Enrollment (Estimated): 356
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenyi Zhang, MMed; Phone Number: +86 021 5203 9999; Email: wenyizhang3827@sjtu.edu.cn
• Study Contact Backup: Name: Birong Wu, MMed; Phone Number: +86 021 5203 9999; Email: shtrcri@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai sixth people's hospital
      • Contact: Hui Zhang, MD; Phone Number: +86 021-64369181-8309; Email: zhanghui@sjtu.edu.cn
      • Principal Investigator: Hui Zhang, MD
    • Shanghai, Shanghai Municipality, China
      • Shanghai Xuhui Central Hospital
      • Contact: Zhen Zheng, MD; Phone Number: +86 021-31270810; Email: zaczeng@163.com
      • Principal Investigator: Zhen Zheng, MD
      • Sub-Investigator: Xiaoxue Qin, MMed
    • Shanghai, Shanghai Municipality, China, 200336
      • Shanghai Tongren Hospital
      • Contact: Wenyi Zhang; Phone Number: +86 021 5203 9999; Email: wenyizhang3827@sjtu.edu.cn
      • Contact: Junfeng Zhang, MD; Phone Number: +86 021 5203 9999; Email: zhangjunfeng@sjtu.edu.cn
      • Principal Investigator: Wenyi Zhang, MMed
      • Sub-Investigator: Yongchen Cui, MMed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: Costoclavicular Brachial Plexus Block; 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.; Procedure: Superficial Cervical Plexus Block; 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.; Procedure: T2 Thoracic Paravertebral Block; 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.
Active Comparator: 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).	Procedure: Superficial Cervical Plexus Block; 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.; Procedure: T2 Thoracic Paravertebral Block; 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.; Procedure: Interscalene Brachial Plexus Block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative (assessed immediately after surgical incision and throughout the procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	20 minutes after nerve block completion
Vasoactive Medication Requirements	Total intraoperative doses of vasoactive medications including urapidil, ephedrine, phenylephrine, and atropine.	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%.	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.	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.	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.	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.	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.	Intraoperative and up to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Shanghai Tong Ren Hospital
• Collaborators: Shanghai 6th People's Hospital
• Investigators: Study Chair: Junfeng Zhang, MD, Shanghai Tong Ren Hospital; Principal Investigator: Wenyi Zhang, MMed, Shanghai Tong Ren Hospital; Principal Investigator: Hui Zhang, MD, Shanghai 6th People's Hospital; Principal Investigator: Zhen Zeng, MD, Shanghai Xuhui Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Elderly; Randomized Controlled Trial; Interscalene Block; Diaphragmatic Paralysis; Proximal Humeral Fracture; Costoclavicular Block
• Additional Relevant MeSH Terms: Shoulder Injuries; Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Respiratory Tract Diseases; Respiration Disorders; Fractures, Bone; Respiratory Insufficiency; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Fractures; Respiratory Paralysis
• Other Study ID Numbers: SHTR-2026-CCB-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No