Dexamethasone Palmitate for Postoperative Pain

NCT07341854 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-041-02-04
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Dexamethasone Palmitate

Outcome Measures

Primary Outcomes (1)

• The percentage of participants experiencing moderate to severe pain

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

  24 hours after surgery

Secondary Outcomes (11)

• Cumulative opioid consumption

  At 6, 24, 48, and 72 hours postoperatively

• The total consumption of supplemental oxycodone/paracetamol tablets

  At 6, 24, 48, and 72 hours postoperatively

• The proportion of participants experiencing moderate to severe pain

  At 6, 24, 48, and 72 hours postoperatively

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

  Within the first 72 hours postoperatively

• Participant satisfaction with pain management

  At 6, 24, 48, and 72 hours postoperatively and at discharge

Study Arms (2)

Dexamethasone palmitate group

EXPERIMENTAL

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

Dexamethasone group

ACTIVE COMPARATOR

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

Interventions

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 palmitate group

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.

Dexamethasone group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ）Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
• \) Willingness to participate voluntarily and provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Electric Power Hospital: collaborator
• Beijing Tiantan Hospital: lead
• Beijing Ditan Hospital: collaborator

Study Sites (1)

Fang Luo

Beijing, 100050, China

Location

Related Publications (9)

• Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.

  PMID: 24237004 BACKGROUND

• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

  PMID: 12873949 BACKGROUND

• Liu Y, Xiao S, Yang H, Lv X, Hou A, Ma Y, Jiang Y, Duan C, Mi W; CAPOPS Group. Postoperative pain-related outcomes and perioperative pain management in China: a population-based study. Lancet Reg Health West Pac. 2023 Jun 10;39:100822. doi: 10.1016/j.lanwpc.2023.100822. eCollection 2023 Oct.

  PMID: 37927993 BACKGROUND

• Gandhi K, Heitz JW, Viscusi ER. Challenges in acute pain management. Anesthesiol Clin. 2011 Jun;29(2):291-309. doi: 10.1016/j.anclin.2011.04.009.

  PMID: 21620344 BACKGROUND

• Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

  PMID: 29026331 BACKGROUND

• Tammachote N, Kanitnate S. Intravenous Dexamethasone Injection Reduces Pain From 12 to 21 Hours After Total Knee Arthroplasty: A Double-Blind, Randomized, Placebo-Controlled Trial. J Arthroplasty. 2020 Feb;35(2):394-400. doi: 10.1016/j.arth.2019.09.002. Epub 2019 Sep 7.

  PMID: 31587982 BACKGROUND

• Kitcharanant N, Leurcharusmee P, Atthakomol P, Jingjit W. Perioperative intravenous dexamethasone did not reduce the severity of persistent postsurgical pain after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. J Orthop Surg Res. 2024 Dec 19;19(1):854. doi: 10.1186/s13018-024-05362-y.

  PMID: 39702151 BACKGROUND

• Lorscheider M, Tsapis N, Ur-Rehman M, Gaudin F, Stolfa I, Abreu S, Mura S, Chaminade P, Espeli M, Fattal E. Dexamethasone palmitate nanoparticles: An efficient treatment for rheumatoid arthritis. J Control Release. 2019 Feb 28;296:179-189. doi: 10.1016/j.jconrel.2019.01.015. Epub 2019 Jan 16.

  PMID: 30659904 BACKGROUND

• Hui H, Miao H, Qiu F, Lin Y, Li H, Zhang Y, Jiang B. Adjunctive dexamethasone palmitate use for intercostal nerve block after video-assisted thoracoscopic surgery: A prospective, randomized control trial. Heliyon. 2023 Aug 22;9(9):e19156. doi: 10.1016/j.heliyon.2023.e19156. eCollection 2023 Sep.

  PMID: 37662806 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

dexamethasone 21-palmitate; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Fang Luo

CONTACT

59976661; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 1. Due to the visually distinct formulations-an opaque, white suspension (dexamethasone palmitate) versus a transparent solution (conventional dexamethasone)-blinding of the anaesthesiologists will not be feasible. 2. This unavoidable lack of blinding at the point of administration made it highly probable that the attending surgeons and the participants themselves could become aware of the treatment group assignment. 3. All postoperative follow-up evaluations will be conducted by outcome assessors who remain fully blinded to group allocation throughout the study. 4. The biostatistician will be blinded and will have no access to interim data until database lock.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)