Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure

Liver Cancer Clinical Trial

Official title:

Study of Parecoxib Versus Celecoxib Versus Oxycodone on Perioperative Pain Control of Transcatheter Chemoembolization Procedure for Patients With Hepatocelullar Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059238
• Other study ID #: 2016-FXY-099
• Status: Completed
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: August 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Pain Postoperative
• Pain, Postoperative

Intervention

Drug:
• Celecoxib 200mg oral capsule

• parecoxib sodium

• controlled-release oxycodone

Locations

Country	Name	City	State
China	Minimally Invasive Interventional Division, Department of Medical Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center,	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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( — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Trouble sleeping	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
Secondary	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
Secondary	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
Secondary	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