dexamethasone palmitate: Patients assigned to the dexamethasone palmitate group will receive an intravenous injection of 8 mg dexamethasone palmitate after induction of anaesthesia but prior to surgical incision.
Dexamethasone: Patients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
The percentage of participants experiencing moderate to severe pain — 24 hours after surgery The percentage of participants experiencing moderate to severe pain (Visual Analog Scale \[VAS\]\>30 mm)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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