Dexamethasone Palmitate for Postoperative Pain

Capital Medical University

Status: Not yet enrolling

Conditions: Pain, Postoperative; Dexamethasone Palmitate

Treatments: Drug: dexamethasone palmitate; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07341854

KY2025-041-02-04

Details and patient eligibility

About

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.

Enrollment: 446 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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. 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. Significant cognitive impairment or severe psychiatric disorder.
7. Pregnancy or lactation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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446 participants in 2 patient groups

Dexamethasone palmitate group

Experimental group

Description:

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.

Treatment:

Drug: dexamethasone palmitate

Dexamethasone group

Active Comparator group

Description:

Patients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision.

Treatment:

Drug: Dexamethasone