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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

446

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Beijing Tiantan Hospital

Collaborators

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)

June 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Pain, Postoperative

Clinical Trials on dexamethasone palmitate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe