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

Shanghai Jiao Tong University

Status: Withdrawn

Conditions: Anesthesia, Regional; Proximal Humeral Fracture; Diaphragmatic Paralysis

Treatments: Procedure: Costoclavicular Brachial Plexus Block; Procedure: T2 Thoracic Paravertebral Block; Procedure: Interscalene Brachial Plexus Block; Procedure: Superficial Cervical Plexus Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07612514

SHTR-2026-CCB-001

Details and patient eligibility

About

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.

Full description

See brief summary.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Costoclavicular Block Group

Experimental group

Description:

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).

Treatment:

Procedure: Superficial Cervical Plexus Block

Procedure: T2 Thoracic Paravertebral Block

Procedure: Costoclavicular Brachial Plexus Block

Interscalene Block Group

Active Comparator group

Description:

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).

Treatment:

Procedure: Superficial Cervical Plexus Block

Procedure: T2 Thoracic Paravertebral Block

Procedure: Interscalene Brachial Plexus Block