Dexamethasone Palmitate for Postoperative Pain

Официальное название

Effect of Intravenous Dexamethasone Palmitate on Postoperative Pain Prevention

Обзор

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.

Вмешательства

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

Первичные конечные точки

• The percentage of participants experiencing moderate to severe pain [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (11)

• Cumulative opioid consumption [Срок оценки: At 6, 24, 48, and 72 hours postoperatively]
• The total consumption of supplemental oxycodone/paracetamol tablets [Срок оценки: At 6, 24, 48, and 72 hours postoperatively]
• The proportion of participants experiencing moderate to severe pain [Срок оценки: At 6, 24, 48, and 72 hours postoperatively]
• Time to first patient-controlled analgesia (PCA) bolus request [Срок оценки: Within the first 72 hours postoperatively]
• Participant satisfaction with pain management [Срок оценки: At 6, 24, 48, and 72 hours postoperatively and at discharge]
• Incidences of postoperative nausea and vomiting (PONV) [Срок оценки: At 6, 24, 48, and 72 hours after surgery]
• Quality of recovery [Срок оценки: At 24, 48, and 72 hours postoperatively, as well as at 1 month after surgery.]
• Length of hospital stay [Срок оценки: 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 [Срок оценки: Within six month after surgery]
• Pain intensity [Срок оценки: 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 [Срок оценки: Within the first 72 hours postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Fang Luo — Пекин

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07341854 · KY2025-041-02-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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