Pain, PostoperativeNCT07341854
Dexamethasone Palmitate for Postoperative Pain
A study testing dexamethasone palmitate and Dexamethasone in people with Pain, Postoperative and Dexamethasone Palmitate, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Dexamethasone Palmitate
- What is being tested?
- dexamethasone palmitate and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 5) Willingness to participate voluntarily and provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fang Luo
Beijing, China, 100050
Fang Luo, 59976661, 13611326978@163.com
About this study
Official title: 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.
- Conditions
- Pain, Postoperative, Dexamethasone Palmitate
- Being tested
- dexamethasone palmitate, Dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone palmitateDrug
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.
DexamethasoneDrug
Patients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants experiencing moderate to severe pain
The percentage of participants experiencing moderate to severe pain (Visual Analog Scale [VAS]>30 mm)
Measured: 24 hours after surgery
Secondary outcomes (11)
Cumulative opioid consumption
Cumulative opioid consumption, expressed as morphine milligram equivalents (MME)
Measured: At 6, 24, 48, and 72 hours postoperatively
The total consumption of supplemental oxycodone/paracetamol tablets
The total consumption of supplemental oxycodone/paracetamol tablets, expressed as the number of tablets
Measured: At 6, 24, 48, and 72 hours postoperatively
The proportion of participants experiencing moderate to severe pain
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)
Measured: At 6, 24, 48, and 72 hours postoperatively
Time to first patient-controlled analgesia (PCA) bolus request
Time to first PCA bolus request
Measured: Within the first 72 hours postoperatively
Participant satisfaction with pain management
Using a 0-10 point numerical rating scale (NRS) (0 = very dissatisfied to 10 = most satisfied imaginable)
Measured: At 6, 24, 48, and 72 hours postoperatively and at discharge
Incidences of postoperative nausea and vomiting (PONV)
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.
Measured: At 6, 24, 48, and 72 hours after surgery
Quality of recovery
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.
Measured: At 24, 48, and 72 hours postoperatively, as well as at 1 month after surgery.
Length of hospital stay
Length of hospital stay was defined as the number of days from the date of hospital admission to the date of discharge.
Measured: 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
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.
Measured: Within six month after surgery
Pain intensity
(0 = no pain, 100mm = worst imaginable pain)
Measured: 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
Participant' total PCA attempts
patients' total PCA attempts
patients' total PCA attempts
Measured: Within the first 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start6 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 446 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Ditan Hospital, Beijing Electric Power Hospital, Beijing Sanbo Brain Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341854
- Sponsor's protocol ID
- KY2025-041-02-04
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 24237004Apfelbaum 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.
PubMed 12873949Liu 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.
PubMed 37927993Gandhi 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.
PubMed 21620344Gan 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.
PubMed 29026331Tammachote 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.
PubMed 31587982Kitcharanant 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.
PubMed 39702151Lorscheider 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.
PubMed 30659904Hui 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.
PubMed 37662806Jiang L, Zhao C, Dong P, Yang L, Han W, Hao C, Wang T, Luo F. TARGET Study: Intravenous Dexamethasone Palmitate for Postoperative Pain Prevention: Protocol for a Multicenter, Randomised Controlled Study. J Pain Res. 2026 Sep 23;19:623960. doi: 10.2147/JPR.S623960. eCollection 2026.
PubMed 42802795
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Dexamethasone Palmitate on Postoperative Pain Prevention
- ClinicalTrials.gov ID
- NCT07341854
- Acronym / sponsor ID
- KY2025-041-02-04
- Conditions
- Pain, Postoperative, Dexamethasone Palmitate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Ditan Hospital, Beijing Electric Power Hospital, Beijing Sanbo Brain Hospital
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone palmitate group | Experimental | Drug: dexamethasone palmitatePatients 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 | Active comparator | Drug: DexamethasonePatients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 5) Willingness to participate voluntarily and provide written informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone palmitatePatients 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 group |
| DexamethasonePatients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision. | Drug | Dexamethasone group |
Primary outcome
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)
11 secondary outcomes
Cumulative opioid consumption
Time frame: 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 proportion of participants experiencing moderate to severe pain
Time frame: 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
Participant satisfaction with pain management
Time frame: 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
Quality of recovery
Time frame: 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).
Incidence of postoperative adverse events
Time frame: 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.
total PCA attempts
Time frame: Within the first 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 24237004Gan 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.
- Background: PubMed 12873949Apfelbaum 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.
- Background: PubMed 37927993Liu 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.
- Background: PubMed 21620344Gandhi 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.
- Background: PubMed 29026331Gan 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.
- Background: PubMed 31587982Tammachote 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.
- Background: PubMed 39702151Kitcharanant 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.
- Background: PubMed 30659904Lorscheider 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.
- Background: PubMed 37662806Hui 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.
- Derived from this study: PubMed 42802795Jiang L, Zhao C, Dong P, Yang L, Han W, Hao C, Wang T, Luo F. TARGET Study: Intravenous Dexamethasone Palmitate for Postoperative Pain Prevention: Protocol for a Multicenter, Randomised Controlled Study. J Pain Res. 2026 Sep 23;19:623960. doi: 10.2147/JPR.S623960. eCollection 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexamethasone palmitate and Dexamethasone in people with Pain, Postoperative and Dexamethasone Palmitate, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo (59976661, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of participants experiencing moderate to severe pain (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07341854, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.