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NCT06041425CompletedPhase 4

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

The Effects of Single Dose Oxycodone Versus Sufentanil on Pain and Inflammatory Response After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: a Randomized Controlled Study

Source: ClinicalTrials.gov · Last updated 28 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
40 (actual)
First submitted
9 Aug 2023
Start date
7 Aug 2023
Primary completion date
17 Dec 2023
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06041425

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 40
  • From 7 Aug 2023 to the primary completion date, 17 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Other

  • Extrahepatic metastasis and/or microvascular invasion;
  • Severe liver and kidney dysfunction;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital with Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.