Dexamethasone Palmitate for Postoperative Pain: A New Lipid-Formulated Option

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial investigates a lipophilic prodrug, dexamethasone palmitate, given before surgery to target inflammatory sites and reduce pain after various procedures. It compares dexamethasone palmitate with standard dexamethasone to see if it lowers pain scores and opioid needs without increased side effects. The study includes adults 18–65 undergoing a range of general anesthesia surgeries, from minimally invasive to open procedures. Primary outcomes focus on postoperative pain intensity and analgesic consumption, with safety monitoring for corticosteroid-related adverse events. The trial is conducted at Beijing Tiantan Hospital and partner centers in Beijing, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-65 years.
2. Scheduled for a range of surgeries under general anesthesia, including both minimally invasive procedures (such as video-assisted thoracoscopic surgery and laparoscopy) and open surgeries (such as thoracotomy, laparotomy, spinal surgery, total joint replacement, and mastectomy).
3. Capacity to comprehend the study procedures and assessment scales, and communicate effectively with research staff.

4）Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.

5\) Willingness to participate voluntarily and provide written informed consent.

Exclusion Criteria:

1. Known hypersensitivity to dexamethasone or its excipients.
2. Systemic glucocorticoid therapy within 3 months prior to enrolment.
3. History of severe cardiovascular disease, hepatic or renal failure, or systemic rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus).
4. Coexisting chronic pain at enrolment.
5. Uncontrolled diabetes mellitus or active systemic infection.
6. Use of any systemic or topical analgesics within 48 hours prior to surgery.
7. Significant cognitive impairment or severe psychiatric disorder.
8. Pregnancy or lactation.

Where it's running

• Fang Luo
  Beijing, China, China Recruiting

Study contacts

• Study coordinator: Fang Luo
• Email: 13611326978@163.com
• Phone: 59976661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.