Clinical trial NCT06041425: The Effects of Oxycodone Versus Sufentanil on Pain and Inflammatory Response After TACE
Official title: The Effects of Single Dose Oxycodone Versus Sufentanil on Pain and Inflammatory Response After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Transcatheter Arterial Chemoembolization
Pain
Inflammation
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, double-blind trial was to compare the effects of preemptive Oxycodone and sufentanil at the same dose on pain and inflammatory response after transcatheter arterial chemoembolization (TACE) of hepatocellular carcinoma. To study the effect of single dose intravenous injection of Oxycodone and sufentanil before TACE on inflammatory reaction after TACE; And (ii) evaluate the effects of different opioid drugs on pain and nausea/vomiting after TACE.

Detailed description: Transcatheter arterial chemoembolization (TACE) is currently considered as the treatment for unresectable hepatocellular carcinoma (HCC). Due to sudden blockage of the main blood vessels supplying the tumor, local liver tissue swells and the tumor rapidly necroses. A large number of inflammatory mediators, including white blood cell (WBC) count, C-reactive protein (CRP) and Interleukin 6 (IL-6), will inevitably appear in TACE induced ischemic and/or necrotic tissue reactions, which contribute to the development of pain. Pain can worsen the patient's quality of life, prolong hospital stay, and increase costs. 93% of patients require opioid therapy during and after TACE.

Opioids are the most common drugs for treating pain. There are three types of opioid receptors, μ Receptors κ Receptors and δ Receptors. Sufentanil is a highly selective drug μ Receptor agonists have fast onset and strong analgesic effects. However, sufentanil is not as effective as Oxycodone in relieving visceral pain. Oxycodone not only activates μ receptors, also occupying κ receptors, alleviate visceral ischemic pain and inflammatory reactions.

In addition to the type of medication, the administration time can also affect perioperative pain. Preemptive analgesia refers to the intervention of pain relief before nociceptive stimuli to suppress the progression of stress states and central sensitization.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years;
* Presence of histologically confirmed or clinically diagnosed hepatocellular carcinoma (fulfilling the criteria for lesions with typical imaging);
* Presence of Child-Pugh class A or B disease;
* Absence of benefit from a treatment of established efficacy such as resection and local ablation;
* ECOG:0-2.

Exclusion Criteria:

* Extrahepatic metastasis and/or microvascular invasion;
* Severe liver and kidney dysfunction;
* Uncontrolled or significant cardiovascular disease; Autoimmune hepatitis; Long term use of opioids, steroid hormones, and non steroidal anti-inflammatory drugs; Abnormal elevation of C-reactive protein (CRP); Increased white blood cells (\>11000/mm3); Study Drugs allergy; Patients who were treated within 4 weeks after COVID-19 infection was diagnosed.

Primary outcomes:
measure: Intraoperative pain intensity during TACE.
timeFrame: Intraoperative (From the beginning of TACE to the end of TACE.)
measure: Pain intensity at 1hour after the end of TACE.
timeFrame: From 0 to 1 hour after the end of TACE.
measure: Pain intensity at 6hours after the end of TACE.
timeFrame: From 1hour to 6 hours after the end of TACE.
measure: Pain intensity at 12hours after the end of TACE.
timeFrame: From 6hours to 12 hours after the end of TACE.
measure: Pain intensity at 24hours after the end of TACE.
timeFrame: From 12 hours to 24 hours after the end of TACE.
Secondary outcomes:
measure: The WBC count
timeFrame: 24 hours
measure: Neutrophil percentage
timeFrame: 24 hours
measure: Level of CRP
timeFrame: 24 hours
measure: Level of IL-6
timeFrame: 24 hours
measure: Nausea and vomiting scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Yu CHEN, MD
role: STUDY_CHAIR
References: