About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- dexamethasone palmitate
- Dexamethasone
Treatment groups
Sponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
Beijing Ditan Hospital
Collaborator
Beijing Electric Power Hospital
Collaborator