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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Pain Postoperative; Liver Cancer

Treatments: Drug: controlled-release oxycodone; Drug: parecoxib sodium; Drug: Celecoxib 200mg oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03059238

2016-FXY-099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 213 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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213 participants in 3 patient groups

Celecoxib group

Experimental group

Description:

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.

Treatment:

Drug: Celecoxib 200mg oral capsule

Parecoxib group

Experimental group

Description:

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.

Treatment:

Drug: parecoxib sodium

Oxycodone group

Experimental group

Description:

Controlled-release oxycodone, 10 mg, orally one hour before TACE and once every 12 hours for 2 days after TACE, with totally 5 times.

Treatment:

Drug: controlled-release oxycodone