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Hepatocellular CarcinomaPhase 4NCT06041425

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

A Phase 4 study testing Oxycodone and Sufentanil in people with Hepatocellular Carcinoma and Transcatheter Arterial Chemoembolization, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxycodone and Sufentanil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
7 Aug 2023to 25 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Oxycodone, Sufentanil
Medical subject headings
Carcinoma, Hepatocellular, Pain, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxycodoneDrug

    Also called preemptive analgesia

    The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE). WBC count, neutrophil percentage, CRP, and IL-6 were used as inflammatory markers and measured before TACE (1 day before TACE) and 24 hours after TACE. Assess pain and side effects during TACE and within 24 hours after TACE. Pain was evaluated using the 11 point Numeric Rating Scale (NRS).

  • SufentanilDrug

    Also called preemptive analgesia

    The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE). WBC count, neutrophil percentage, CRP, and IL-6 were used as inflammatory markers and measured before TACE (1 day before TACE) and 24 hours after TACE. Assess pain and side effects during TACE and within 24 hours after TACE. Pain was evaluated using the 11 point Numeric Rating Scale (NRS).

Study groups in NCT06041425
Study groupRoleWhat they receive
OxycodoneExperimentalThe patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE).
Receives: Drug: Oxycodone
SufentanilActive comparatorThe patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE).
Receives: Drug: Sufentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative pain intensity during 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).

    Measured: Intraoperative (From the beginning of TACE to the end of TACE.)

  2. Pain intensity at 1hour 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).

    Measured: From 0 to 1 hour after the end of TACE.

  3. Pain intensity at 6hours 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).

    Measured: From 1hour to 6 hours after the end of TACE.

  4. Pain intensity at 12hours 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).

    Measured: From 6hours to 12 hours after the end of TACE.

  5. Pain intensity at 24hours 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).

    Measured: From 12 hours to 24 hours after the end of TACE.

Secondary outcomes (5)

  1. The WBC count

    The WBC count in 10^9/L. Inflammatory reactions

    Measured: 24 hours

  2. Neutrophil percentage

    neutrophil percentage in %.

    Inflammatory reactions

    Measured: 24 hours

  3. Level of CRP

    CRP in mg/L.

    Inflammatory reaction

    Measured: 24 hours

  4. Level of IL-6

    IL-6 in pg/mL.

    Inflammatory reaction

    Measured: 24 hours

  5. Nausea and vomiting scale

    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.)

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2023
  2. Study start7 Aug 2023
  3. Primary completion17 Dec 2023
  4. Study completion25 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06041425
Sponsor's protocol ID
2023-SR-093
Status last verified
Feb 2024
First submitted
9 Aug 2023
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.

Publications

  • Wu WT, Xu BJ, Li B, Hang Y, Zu QQ, Zhou WZ, Liu S, Shi HB, Chen Y. Pre-emptive Oxycodone versus Sufentanil for Acute and Delayed Pain after Transcatheter Arterial Chemoembolization: A Randomized Controlled Trial with Inflammatory Biomarker Analysis. J Vasc Interv Radiol. 2026 May;37(5):108570. doi: 10.1016/j.jvir.2026.108570. Epub 2026 Jan 30.

    PubMed 41621790

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxycodone and Sufentanil in people with Hepatocellular Carcinoma and Transcatheter Arterial Chemoembolization, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative pain intensity during TACE. (time frame: Intraoperative (From the beginning of TACE to the end of TACE.)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06041425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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