Dexamethasone Palmitate for Postoperative Pain

NCT ID: NCT07341854

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

446 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-02

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative Dexamethasone Palmitate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

dexamethasone palmitate

Intervention Type 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 group

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Ditan Hospital

OTHER

Sponsor Role collaborator

Beijing Electric Power Hospital

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fang Luo

Director of Department of Pain Management

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fang Luo

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Fang Luo

Role: CONTACT

Facility Contacts

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Fang Luo

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 24237004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12873949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37927993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21620344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29026331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31587982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39702151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30659904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37662806 (View on PubMed)

Other Identifiers

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KY2025-041-02-04

Identifier Type: -

Identifier Source: org_study_id

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