Clinical trial NCT03059238: Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure
Official title: Study of Parecoxib Versus Celecoxib Versus Oxycodone on Perioperative Pain Control of Transcatheter Chemoembolization Procedure for Patients With Hepatocelullar Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Cancer
Pain Postoperative
Keywords: Pain control
TACE
Opioids
NSAIDs
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients included in the study were classified with stage B or C according to the Barcelona Clinic Liver Cancer (BCLC) staging classification.
* Patients were recommended to receive TACE therapy for HCC.

Exclusion Criteria:

* hypersensitive to celecoxib, parecoxib, and oxycodone
* a history of serious allergic reactions to medicines
* stomach ulcers or bleeding in the stomach or gut
* allergic-type reactions such as bronchospasm, cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors
* severe liver disease
* inflammatory bowel disease
* heart failure, ischaemic heart disease, peripheral artery disease, or cerebrovascular disease
* women during the last three months of pregnancy or to breast-feeding women
* after coronary surgery

Primary outcomes:
measure: Pain score
timeFrame: 48 hours
Secondary outcomes:
measure: Adverse events
timeFrame: 48 hours
measure: Trouble sleeping
timeFrame: 48 hours
measure: Fatigue
timeFrame: 48 hours
measure: Lacked appetite
timeFrame: 48 hours
measure: Spiritual state
timeFrame: 48 hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Minimally Invasive Interventional Division, Department of Medical Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center,
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.