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

Primary Purpose

Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Pain

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Oxycodone
Sufentanil
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital with Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxycodone

Sufentanil

Arm Description

The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE).

The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE).

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).

Secondary Outcome Measures

The WBC count
The WBC count in 10^9/L. Inflammatory reactions
Neutrophil percentage
neutrophil percentage in %. Inflammatory reactions
Level of CRP
CRP in mg/L. Inflammatory reaction
Level of IL-6
IL-6 in pg/mL. Inflammatory reaction
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.)

Full Information

First Posted
August 9, 2023
Last Updated
September 15, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06041425
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Pain, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone
Arm Type
Experimental
Arm Description
The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE).
Arm Title
Sufentanil
Arm Type
Active Comparator
Arm Description
The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE).
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
preemptive analgesia
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Other Intervention Name(s)
preemptive analgesia
Intervention Description
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).
Primary Outcome Measure Information:
Title
Intraoperative pain intensity during TACE.
Description
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).
Time Frame
Intraoperative (From the beginning of TACE to the end of TACE.)
Title
Pain intensity at 1hour after the end of TACE.
Description
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).
Time Frame
From 0 to 1 hour after the end of TACE.
Title
Pain intensity at 6hours after the end of TACE.
Description
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).
Time Frame
From 1hour to 6 hours after the end of TACE.
Title
Pain intensity at 12hours after the end of TACE.
Description
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).
Time Frame
From 6hours to 12 hours after the end of TACE.
Title
Pain intensity at 24hours after the end of TACE.
Description
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).
Time Frame
From 12 hours to 24 hours after the end of TACE.
Secondary Outcome Measure Information:
Title
The WBC count
Description
The WBC count in 10^9/L. Inflammatory reactions
Time Frame
24 hours
Title
Neutrophil percentage
Description
neutrophil percentage in %. Inflammatory reactions
Time Frame
24 hours
Title
Level of CRP
Description
CRP in mg/L. Inflammatory reaction
Time Frame
24 hours
Title
Level of IL-6
Description
IL-6 in pg/mL. Inflammatory reaction
Time Frame
24 hours
Title
Nausea and vomiting scale
Description
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.)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wentao WU, MD
Phone
15251836687 ext +86
Ext
02568306918
Email
doctorwuwentao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu CHEN, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wentao WU, MD
Phone
(+86)15251836687
Email
doctorwuwentao@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data for this study is available from the sponsor on reasonable request through email.
IPD Sharing Time Frame
August 2023 to August 2024
IPD Sharing Access Criteria
Within one year

Learn more about this trial

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

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