Liver Cancer, Pain Postoperative
Conditions
Keywords
Pain control, TACE, Opioids, NSAIDs
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.
Interventions
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 48 hours | Self reported pain intensity using the numeric rating scale (NRS) (score of 0-10) after administration of the first dose of study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trouble sleeping | 48 hours | 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. |
| Adverse events | 48 hours | 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. |
| Fatigue | 48 hours | 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. |
| Lacked appetite | 48 hours | 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. |
| Spiritual state | 48 hours | 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. |
Countries
China
Outcome results
None listed