Dexamethasone Palmitate for Postoperative Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital

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

446 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Tiantan Hospital

Lead sponsor

Beijing Ditan Hospital

Collaborator

Beijing Electric Power Hospital

Collaborator