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The purpose of this randomized, double-blind trial was to compare the effects of preemptive Oxycodone and sufentanil at the same dose on pain and inflammatory response after transcatheter arterial chemoembolization (TACE) of hepatocellular carcinoma. To study the effect of single dose intravenous injection of Oxycodone and sufentanil before TACE on inflammatory reaction after TACE; And (ii) evaluate the effects of different opioid drugs on pain and nausea/vomiting after TACE.
Transcatheter arterial chemoembolization (TACE) is currently considered as the treatment for unresectable hepatocellular carcinoma (HCC). Due to sudden blockage of the main blood vessels supplying the tumor, local liver tissue swells and the tumor rapidly necroses. A large number of inflammatory mediators, including white blood cell (WBC) count, C-reactive protein (CRP) and Interleukin 6 (IL-6), will inevitably appear in TACE induced ischemic and/or necrotic tissue reactions, which contribute to the development of pain. Pain can worsen the patient's quality of life, prolong hospital stay, and increase costs. 93% of patients require opioid therapy during and after TACE.
Opioids are the most common drugs for treating pain. There are three types of opioid receptors, μ Receptors κ Receptors and δ Receptors. Sufentanil is a highly selective drug μ Receptor agonists have fast onset and strong analgesic effects. However, sufentanil is not as effective as Oxycodone in relieving visceral pain. Oxycodone not only activates μ receptors, also occupying κ receptors, alleviate visceral ischemic pain and inflammatory reactions.
In addition to the type of medication, the administration time can also affect perioperative pain. Preemptive analgesia refers to the intervention of pain relief before nociceptive stimuli to suppress the progression of stress states and central sensitization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone | Experimental | The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE). |
|
| Sufentanil | Active Comparator | The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE). WBC count, neutrophil percentage, CRP, and IL-6 were used as inflammatory markers and measured before TACE (1 day before TACE) and 24 hours after TACE. Assess pain and side effects during TACE and within 24 hours after TACE. Pain was evaluated using the 11 point Numeric Rating Scale (NRS). |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative pain intensity during TACE. | Pain intensity is assessed by numerical rating scale pain scores (0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome). | Intraoperative (From the beginning of TACE to the end of TACE.) |
| Pain intensity at 1hour after the end of TACE. | Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome). | From 0 to 1 hour after the end of TACE. |
| Pain intensity at 6hours after the end of TACE. | Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome). | From 1hour to 6 hours after the end of TACE. |
| Pain intensity at 12hours after the end of TACE. | Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome). | From 6hours to 12 hours after the end of TACE. |
| Pain intensity at 24hours after the end of TACE. | Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome). | From 12 hours to 24 hours after the end of TACE. |
| Measure | Description | Time Frame |
|---|---|---|
| The WBC count | The WBC count in 10^9/L. Inflammatory reactions | 24 hours |
| Neutrophil percentage | neutrophil percentage in %. Inflammatory reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu CHEN, MD | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41621790 | Derived | Wu WT, Xu BJ, Li B, Hang Y, Zu QQ, Zhou WZ, Liu S, Shi HB, Chen Y. Pre-emptive Oxycodone versus Sufentanil for Acute and Delayed Pain after Transcatheter Arterial Chemoembolization: A Randomized Controlled Trial with Inflammatory Biomarker Analysis. J Vasc Interv Radiol. 2026 May;37(5):108570. doi: 10.1016/j.jvir.2026.108570. Epub 2026 Jan 30. |
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The individual participant data for this study is available from the sponsor on reasonable request through email.
August 2023 to August 2024
Within one year
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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|
|
| Sufentanil | Drug | The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE). WBC count, neutrophil percentage, CRP, and IL-6 were used as inflammatory markers and measured before TACE (1 day before TACE) and 24 hours after TACE. Assess pain and side effects during TACE and within 24 hours after TACE. Pain was evaluated using the 11 point Numeric Rating Scale (NRS). |
|
|
| 24 hours |
| Level of CRP | CRP in mg/L. Inflammatory reaction | 24 hours |
| Level of IL-6 | IL-6 in pg/mL. Inflammatory reaction | 24 hours |
| Nausea and vomiting scale | Nausea and vomiting were graded on a four-point scale, 0,no nausea.1,mild nausea. 2,severe nausea requiring antiemetics. and 3, retching and/or vomiting.) | 24 hours |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |