The Effects of Oxycodone Versus Sufentanil on Pain and Inflammatory Response After TACE

Phase 4

Completed

• Conditions: Hepatocellular Carcinoma; Transcatheter Arterial Chemoembolization; Pain; Inflammation
• Interventions: Drug: Oxycodone; Drug: Sufentanil

• Registration Number: NCT06041425
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study Start: 2023-08-07
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-18
• Primary Completion: 2023-12-17
• Study Completion: 2023-12-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone	Oxycodone	The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE).
Sufentanil	Sufentanil	The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE).

Primary Outcome Measures

Name	Time	Method
Intraoperative pain intensity during TACE.	Intraoperative (From the beginning of TACE to the end of TACE.)	Pain intensity is assessed by numerical rating scale pain scores (0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).
Pain intensity at 6hours after the end of TACE.	From 1hour to 6 hours after the end of TACE.	Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).
Pain intensity at 24hours after the end of TACE.	From 12 hours to 24 hours after the end of TACE.	Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).
Pain intensity at 1hour after the end of TACE.	From 0 to 1 hour after the end of TACE.	Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).
Pain intensity at 12hours after the end of TACE.	From 6hours to 12 hours after the end of TACE.	Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).

Secondary Outcome Measures

Name	Time	Method
Level of IL-6	24 hours	IL-6 in pg/mL.; Inflammatory reaction
Neutrophil percentage	24 hours	neutrophil percentage in %.; Inflammatory reactions
The WBC count	24 hours	The WBC count in 10\^9/L. Inflammatory reactions
Nausea and vomiting scale	24 hours	Nausea and vomiting were graded on a four-point scale, 0,no nausea.1,mild nausea. 2,severe nausea requiring antiemetics. and 3, retching and/or vomiting.)
Level of CRP	24 hours	CRP in mg/L.; Inflammatory reaction

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China