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The effect of dexamethasone palmitate on the postoperative pain intensity in patients receiving pain control after arthroscopic shoulder surgery using brachial plexus block: a randomized controlled trial

The effect of dexamethasone palmitate on the postoperative pain intensity in patients receiving pain control after arthroscopic shoulder surgery using brachial plexus block: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010028
Enrollment
94
Registered
2024-12-12
Start date
2025-03-24
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Study drug is prepared by a investogator in the seperate pharmacy. This study drug is admistered intravenously after general anesthesia induction to ensure patient blindness. Control group: d

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients undergoing arthroscopic shoulder surgery who are receiving pain control with brachial plexus block. - American Society of Anesthesiologists physical criteria I, II: ex) Healthy adults without underlying diseases (I), patients with systemic diseases such as controlled hypertension or controlled diabetes that can be controlled with medication or surgical treatment (II)

Exclusion criteria

Exclusion criteria: - American Society of Anesthesiologists physical criteria III, IV, V: ex) Patients with systemic diseases such as diabetes with complications (III), Patients with extremely serious systemic diseases requiring immediate treatment (IV), Death (V) - Pregnant or lactating women - Patients with serious blood coagulation disorders (INR 1.5 or higher on the last blood coagulation test before surgery) - Patients with unstable coronary artery disease, congestive heart failure, arrhythmia, or myocarditis - Patients with cerebrovascular disease - Patients with systemic infection, current infection in the area where brachial plexus block will be performed (neck area) - Patients who do not understand this study and express their intention not to participate in the study - Patients with allergies to local anesthetics - Patients with contraindications to the test drugs (dexamethasone disodium phosphate and dexamethasone palmitate) * Patients with hypersensitivity to this drug or its components or a history of hypersensitivity * Lactating women * Hypersensitivity to soybean oil or Patients with a history of allergies * Patients with hypersensitivity to soybeans or peanuts * Patients with intra-articular, intrabursal, intra-tendon, or peri-tendon infections * Patients with joint instability * Patients receiving live vaccines * Patients with herpes simplex, shingles, or chickenpox * Patients with infections for which there are no effective antimicrobial agents, systemic fungal infections - Patients who have failed brachial plexus block

Design outcomes

Primary

MeasureTime frame
pain intensity during 24 h after brachial plexus block (Weighted AUC = [Area under curve of pain score at 4h 8h 12h 24h]/24)

Secondary

MeasureTime frame
Pain scores before and after brachial plexus block (at rest and during mobilization);Worst pain score during 48 h after brachial plexus block;opioid comsumption;Time to lock resolution;Patient satisfaction for fist night sleep quality, and postoperative analgesia for 24h after surgery;nausea and vomiting after brachial plexus block ;dizziness after brachial plexus block ;respiratory depression after brachial plexus block

Countries

Korea, Republic of

Contacts

Public ContactYu Jeong Bang

Samsung Medical Center

gagreflex.bang@gmail.com+82-2-1599-3114

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026