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This phase III, randomized, prospective clinical study, aiming to compare the analgesic effects of celecoxib, parecoxib, and oxycodone in patients with inoperable hepatic carcinoma undergoing TACE procedure in postoperative pain control.
Studies reported that almost 75% of patients with hepatocellular carcinoma undergoing transcatheter arterial chemoembolization (TACE) experienced severe pain (in a three-grade mild, moderate, and severe classification), and 93% of patients required opioid treatment during the first 12 hours after TACE.
Opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are most commonly used analgesic medications in the control of postoperative surgical pain. Previous studies has indicated that both controlled-release oxycodone, which is an oral semisynthetic opioid µ and κ agonist, and parecoxib sodium, a parenteral COX-2 selective inhibitor, were effective and safe on peri- and post-procedural pain in HCC patients undergoing TACE.
To the investigators's knowledge, no studies have been developed on comparing differences of efficacy and feasibility of analgesics with different action mechanism (opioids vs. NSAIDs) and administration route (oral path vs. injective path) on pain control for patients undergone TACE. In this phase III, randomized, prospective clinical study, the investigators aimed to compare the analgesic effects of celecoxib (oral NSAIDs), parecoxib (injective NSAIDs), and controlled-release oxycodone (oral opioids) in patients with inoperable hepatic carcinoma undergoing TACE procedure in postoperative pain control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib group | Experimental | Celecoxib 200mg oral capsule, 200 mg, orally one hour before TACE and once every 12 hours for 2 days after TACE, with totally 5 times. |
|
| Parecoxib group | Experimental | Parecoxib sodium , 40 mg, dissolved in 3 mL 0.9% sodium chloride intravenously one hour before TACE and once every 12 hours for 2 days after TACE, with totally 5 times. |
|
| Oxycodone group | Experimental | Controlled-release oxycodone, 10 mg, orally one hour before TACE and once every 12 hours for 2 days after TACE, with totally 5 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib 200mg oral capsule | Drug |
| ||
| parecoxib sodium |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Self reported pain intensity using the numeric rating scale (NRS) (score of 0-10) after administration of the first dose of study medication. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events scores of fever, vomiting, nausea, constipation, dysuria, and hypersomnia were rated according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. | 48 hours |
| Trouble sleeping |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming Zhao, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minimally Invasive Interventional Division, Department of Medical Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, | Guangzhou | Guangdong | 500060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22357901 | Background | Zhou B, Wang J, Yan Z, Shi P, Kan Z. Liver cancer: effects, safety, and cost-effectiveness of controlled-release oxycodone for pain control after TACE. Radiology. 2012 Mar;262(3):1014-21. doi: 10.1148/radiol.11110552. | |
| 27056892 | Background | Zhou ZG, Chen JB, Qiu HB, Wang RJ, Chen JC, Xu L, Chen MS, Zhang YJ. Parecoxib prevents complications in hepatocellular carcinoma patients receiving hepatic transarterial chemoembolization: a prospective score-matched cohort study. Oncotarget. 2016 May 10;7(19):27938-45. doi: 10.18632/oncotarget.8560. |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| C409945 | parecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| controlled-release oxycodone | Drug |
|
Self reported sleep trouble using the numeric rating scale 1-4 (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) once every 24 hours after administration of the first dose of study medication.
| 48 hours |
| Fatigue | Self reported fatigue using the numeric rating scale 1-4 (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) once every 24 hours after administration of the first dose of study medication. | 48 hours |
| Lacked appetite | Self reported lacked appetite using the numeric rating scale 1-4 (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) once every 24 hours after administration of the first dose of study medication. | 48 hours |
| Spiritual state | Self reported fatigue using the numeric rating scale 1-4 (1 = Very well; 2 = normal; 3 = poor; 4 = worst) once every 24 hours after administration of the first dose of study medication. | 48 hours |
| 26801163 | Result | Lv N, Kong Y, Mu L, Pan T, Xie Q, Zhao M. Effect of perioperative parecoxib sodium on postoperative pain control for transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma: a prospective randomized trial. Eur Radiol. 2016 Oct;26(10):3492-9. doi: 10.1007/s00330-016-4207-8. Epub 2016 Jan 22. |
| D008107 |
| Liver Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |