Dexamethasone Palmitate for Postoperative Pain

April 2, 2026 updated by: Fang Luo, Beijing Tiantan Hospital

Effect of Intravenous Dexamethasone Palmitate on Postoperative Pain Prevention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
446

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dexamethasone palmitate group
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.
Drug: 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.
Active Comparator: Dexamethasone group
Patients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision.
Drug: Dexamethasone
Patients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
24 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative opioid consumption
Time Frame: At 6, 24, 48, and 72 hours postoperatively
Cumulative opioid consumption, expressed as morphine milligram equivalents (MME)
At 6, 24, 48, and 72 hours postoperatively
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
At 6, 24, 48, and 72 hours postoperatively
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)
At 6, 24, 48, and 72 hours postoperatively
Time to first patient-controlled analgesia (PCA) bolus request
Time Frame: Within the first 72 hours postoperatively
Time to first PCA bolus request
Within the first 72 hours postoperatively
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)
At 6, 24, 48, and 72 hours postoperatively and at discharge
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.
At 6, 24, 48, and 72 hours after surgery
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.
At 24, 48, and 72 hours postoperatively, as well as at 1 month after surgery.
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.
From the date of hospital admission to the date of discharge, assessed throughout the hospitalization period (up to 1 month).
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.
Within six month after surgery
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)
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.
total PCA attempts
Time Frame: Within the first 72 hours postoperatively

Participant' total PCA attempts

patients' total PCA attempts

patients' total PCA attempts
Within the first 72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Ditan Hospital
Beijing Electric Power Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2025-041-02-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All personal identifiers will be stored securely by the principal investigator, separate from the pseudonymized study data. Access is restricted to the research team, and all published findings will be based on anonymized data aggregates.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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