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NCT Number: NCT07341854

Dexamethasone Palmitate for Postoperative Pain

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.

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Key information

Conditions

Pain, Postoperative Dexamethasone Palmitate Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dexamethasone palmitate

Drug

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

Drug

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

Primary outcomes

  1. The percentage of participants experiencing moderate to severe pain

    Time frame: 24 hours after surgery

    The percentage of participants experiencing moderate to severe pain (Visual Analog Scale [VAS]>30 mm)

Secondary outcomes

  1. Cumulative opioid consumption

    Time frame: At 6, 24, 48, and 72 hours postoperatively

    Cumulative opioid consumption, expressed as morphine milligram equivalents (MME)

  2. The total consumption of supplemental oxycodone/paracetamol tablets

    Time frame: At 6, 24, 48, and 72 hours postoperatively

    The total consumption of supplemental oxycodone/paracetamol tablets, expressed as the number of tablets

  3. The proportion of participants experiencing moderate to severe pain

    Time frame: At 6, 24, 48, and 72 hours postoperatively

    The proportion of participants experiencing moderate to severe pain at rest and during passive movement (e.g., coughing, deep breathing, or following a 5 m walk test)

  4. Time to first patient-controlled analgesia (PCA) bolus request

    Time frame: Within the first 72 hours postoperatively

    Time to first PCA bolus request

  5. Participant satisfaction with pain management

    Time frame: At 6, 24, 48, and 72 hours postoperatively and at discharge

    Using a 0-10 point numerical rating scale (NRS) (0 = very dissatisfied to 10 = most satisfied imaginable)

  6. Incidences of postoperative nausea and vomiting (PONV)

    Time frame: At 6, 24, 48, and 72 hours after surgery

    PONV is defined as any nausea, vomiting, retching, or combination thereof. Nausea refers to an unpleasant sensation associated with the urge to vomit; vomiting is defined as the forceful expulsion of gastric contents; and retching indicates an involuntary attempt to vomit without producing gastric contents.

  7. Quality of recovery

    Time frame: At 24, 48, and 72 hours postoperatively, as well as at 1 month after surgery.

    Quality of recovery will be measured using the 15-item quality of recovery scoring system [QoR-15] questionnaire. The total score ranges from 0 to 150, where higher scores indicate a better quality of recovery.

  8. Length of hospital stay

    Time frame: From the date of hospital admission to the date of discharge, assessed throughout the hospitalization period (up to 1 month).

    Length of hospital stay was defined as the number of days from the date of hospital admission to the date of discharge.

  9. Incidence of postoperative adverse events

    Time frame: Within six month after surgery

    This outcome measure assesses the occurrence of specified safety events within six month after surgery. The number of participants experiencing any of the following confirmed events will be recorded and reported based on clinical examination, medical record review, and necessary laboratory tests: hypotension, hypertension, gastrointestinal ulcers, poor wound healing, surgical site infection, urinary retention, and hyperglycemia. Data will be aggregated and reported as event frequency and participant count.

  10. Pain intensity

    Time frame: upon arrival in the PACU after the patient becomes conscious (0 hour), and at 6, 24, 48, and 72 hours postoperatively, as well as at discharge, and at 1 month, 3 month, and 6 month follow up.

    (0 = no pain, 100mm = worst imaginable pain)

  11. total PCA attempts

    Time frame: Within the first 72 hours postoperatively

    Participant' total PCA attempts

    patients' total PCA attempts

    patients' total PCA attempts

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

59976661

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Ditan Hospital
  • Beijing Electric Power Hospital

Registry information

Official study title

Effect of Intravenous Dexamethasone Palmitate on Postoperative Pain Prevention

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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