Dexamethasone Palmitate for Postoperative Pain

Starting soon · Not applicable

Conditions studied: Pain, Postoperative, Dexamethasone Palmitate

In brief

Postoperative pain remains highly prevalent and inadequately managed in a significant proportion of surgical patients, often leading to delayed recovery, increased opioid consumption, and potential progression to chronic pain. While perioperative systemic dexamethasone is used for its anti-inflammatory and opioid-sparing effects, its efficacy is inconsistent, and concerns regarding systemic side effects persist. Dexamethasone palmitate, a novel lipophilic prodrug formulated as nanoparticle emulsion, leverages the enhanced permeability and retention effect to target inflammatory sites selectively, potentially offering superior anti-inflammatory and analgesic efficacy with reduced systemic exposure. This trial aims to evaluate whether preoperative intravenous dexamethasone palmitate is more effective than conventional dexamethasone in preventing moderate-to-severe postoperative pain.

Key facts

Study ID

NCT07341854

Run by

Beijing Tiantan Hospital

People needed

446

Starts

2026-06-01

Expected to finish

2027-12-30

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65 years.
• 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).
• 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.
• Willingness to participate voluntarily and provide written informed consent.

You may not qualify if…

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

Where it is running

• Fang Luo — Beijing, China

Full record on ClinicalTrials.gov

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