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Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Pain

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esketamine
Sufentanil
Sponsored by
The Second Affiliated Hospital of Chongqing 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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 to 80 Participate in this study and sign informed consent Voluntarily receive preoperative intravenous analgesia Patients receiving TACE treatment HCC (hepatocellular carcinoma)patients with primary liver cancer BCLC(Barcelona Clinic Liver Cancer) stage A-C, liver function A-B Exclusion Criteria: Patients who were unable to cooperate or refused to participate in the trial Pregnant women Patients with or having a history of serious mental disorders Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic / diastolic blood pressure more than 180/100mg) Patients with unstable angina pectoris or myocardial infarction within 6 months or congestive heart failure Patients with intracranial hypertension or glaucoma Patients with hyperthyroidism without treatment or insufficient treatment Patients with severe respiratory dysfunction Allergy or existing contraindication to chemotherapeutic drugs, opioids or ketamine drugs

Sites / Locations

  • The Second Affiliated Hospital, Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Esketamine-PCIA(patient controlled intravenous analgesia)

Sufentanil-PCIA(patient controlled intravenous analgesia)

Arm Description

PCIA formula#100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline.

PCIA formula#100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline.

Outcomes

Primary Outcome Measures

Pain Intensity at 4hours after the beginning of TACE operation
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 8hours after the beginning of TACE operation
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 beginning of TACE operation
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

Pain Intensity at 18hours after the beginning of TACE operation
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 beginning of TACE operation
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 30hours after the beginning of TACE operation
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 36hours after the beginning of TACE operation
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 42hours after the beginning of TACE operation
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 48hours after the beginning of TACE operation
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)
Maximum Pain Intensity in the First 4hours after the beginning of TACE operation
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)
Maximum Pain Intensity in the Second 4hours after the beginning of TACE operation
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)
Maximum Pain Intensity in the Third 4hours after the beginning of TACE operation
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)
Analgesic Consumption
Analgesic consumption is assessed by the total amount of pain remedy with dolantin when the analgesic effect is poor.

Full Information

First Posted
January 2, 2023
Last Updated
March 28, 2023
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05670561
Brief Title
Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma
Official Title
Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma:a Prospective Study TACE(Transcatheter Arterial Chemoembolization)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pain is the main complication after TACE(Transcatheter Arterial Chemoembolization) for hepatocellular carcinoma, and its pathogenesis is not clear.The pain may be related to partial liver tissue swelling after blocking the tumor blood supply artery embolization agent, transient hepatic swelling causing tension or strain on the liver capsule, and chemical irritation by the anticancer drug-Lipiodol mixture,the inadvertent embolization of normal organs and individual sensitivity to pain. Ketamine produces anesthetic and analgesic effects mainly by inhibiting NMDA receptor(N-methyl-D-aspartic acid receptor), and previous studies have shown that low concentrations of ketamine have obvious analgesic effects. Not only that, ketamine also produces analgesic effects by inhibiting opioid receptors via G-protein coupling. In addition, ketamine can bind to monoaminergic receptors in the central and peripheral nervous system, showing an anticholinergic effect and producing an antispasmodic effect. Ketamine also inhibits inflammatory pain by reducing nitric oxide production by inhibiting nitric oxide synthase. Esketamine is about three to four times more potent than ketamine. Therefore,esketamine requires a lower dose, about half the dose of ketamine, to produce anesthetic and analgesic effects, with fewer side effects.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esketamine-PCIA(patient controlled intravenous analgesia)
Arm Type
Experimental
Arm Description
PCIA formula#100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline.
Arm Title
Sufentanil-PCIA(patient controlled intravenous analgesia)
Arm Type
Active Comparator
Arm Description
PCIA formula#100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline.
Intervention Type
Drug
Intervention Name(s)
Esketamine
Other Intervention Name(s)
patient controlled intravenous analgesia
Intervention Description
PCIA formula#100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline. 30min before TACE treatment, the first dose of 2ml was slowly injected intravenously. No obvious adverse reactions were observed for 10min.The PCIA pump was commenced at the beginning of TACE. Parameter setting of intravenous analgesia pump: the total volume is 100ml; The duration is 2ml / h; The single dose is 2ml each time; The limit quantity is 10ml / h; The locking time was 10min and the analgesia lasted for 48h. The target value of analgesia in this study was NRS (Numerical Rating Scale)< 4; If NRS ≥ 4, when the effect is still poor after adding drugs by pressing the analgesic pump, the investigators will give the remedial drug(dolantin 50mg im st) according to the patient's condition.
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Other Intervention Name(s)
patient controlled intravenous analgesia
Intervention Description
PCIA formula#100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline. 30min before TACE treatment, the first dose of 2ml was slowly injected intravenously.No obvious adverse reactions were observed for 10min. The PCIA pump was commenced at the beginning of TACE. Parameter setting of intravenous analgesia pump: the total volume is 100ml; The duration is 2ml / h; The single dose is 2ml each time; The limit quantity is 10ml / h; The locking time was 10min and the analgesia lasted for 48h. The target value of analgesia in this study was NRS (Numerical Rating Scale)< 4; If NRS ≥ 4, when the effect is still poor after adding drugs by pressing the analgesic pump, the investigators will give the remedial drug(dolantin 50mg im st) according to the patient's condition.
Primary Outcome Measure Information:
Title
Pain Intensity at 4hours after the beginning of TACE operation
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 4hours after the beginning of TACE
Title
Pain Intensity at 8hours after the beginning of TACE operation
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 4hours to 8hours after the beginning of TACE operation
Title
Pain Intensity at 12hours after the beginning of TACE operation
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 8hours to 12hours after the beginning of TACE operation
Secondary Outcome Measure Information:
Title
Pain Intensity at 18hours after the beginning of TACE operation
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 12hours to 18hours after the beginning of TACE operation
Title
Pain Intensity at 24hours after the beginning of TACE operation
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 18hours to 24hours after the beginning of TACE operation
Title
Pain Intensity at 30hours after the beginning of TACE operation
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 24hours to 30hours after the beginning of TACE operation
Title
Pain Intensity at 36hours after the beginning of TACE operation
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 30hours to 36hours after the beginning of TACE operation
Title
Pain Intensity at 42hours after the beginning of TACE operation
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 36hours to 42hours after the beginning of TACE operation
Title
Pain Intensity at 48hours after the beginning of TACE operation
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 42hours to 48hours after the beginning of TACE operation
Title
Maximum Pain Intensity in the First 4hours after the beginning of TACE operation
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 the beginning of TACE operation to 4hours after the beginning of TACE operation
Title
Maximum Pain Intensity in the Second 4hours after the beginning of TACE operation
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 4hours to 8hours after the beginning of TACE operation
Title
Maximum Pain Intensity in the Third 4hours after the beginning of TACE operation
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 8hours to 12hours after the beginning of TACE operation
Title
Analgesic Consumption
Description
Analgesic consumption is assessed by the total amount of pain remedy with dolantin when the analgesic effect is poor.
Time Frame
From 0 to 48 hours after the beginning of TACE operation
Other Pre-specified Outcome Measures:
Title
Ramsay Sedation Score at 1 hour after the beginning of TACE operation
Description
Grade 1 (soberness- the patient is anxious, uneasy or irritable)# Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)# Grade 3 (soberness- the patient only responds to commands)# Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)# Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.
Time Frame
From 0 to 1hour after the beginning of TACE operation
Title
Ramsay Sedation Score at 2 hours after the beginning of TACE operation
Description
Grade 1 (soberness- the patient is anxious, uneasy or irritable)# Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)# Grade 3 (soberness- the patient only responds to commands)# Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)# Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.
Time Frame
From 1hour to 2hours after the beginning of TACE operation
Title
Ramsay Sedation Score at 3 hours after the beginning of TACE operation
Description
Grade 1 (soberness- the patient is anxious, uneasy or irritable)# Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)# Grade 3 (soberness- the patient only responds to commands)# Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)# Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.
Time Frame
From 2hours to 3hours after the beginning of TACE operation
Title
The Quality of Sleep on the Day Just before TACE Treatment
Description
The Richards-Campbell Sleep Questionnaire (RCSQ) is assessed by the quality of patients' sleep quality.0~25 points indicate poor sleep quality;76~100 points indicate good sleep quality (0-100, 0 represents the worst sleep quality; 100 represents the best sleep quality ;higher scores mean a better outcome)
Time Frame
From the day just before TACE treatment to the operation day
Title
The Quality of Sleep on the Operation Day
Description
The Richards-Campbell Sleep Questionnaire (RCSQ) is assessed by the quality of patients' sleep quality.0~25 points indicate poor sleep quality;76~100 points indicate good sleep quality (0-100, 0 represents the worst sleep quality; 100 represents the best sleep quality ;higher scores mean a better outcome)
Time Frame
From the operation day to first day after TACE treatment
Title
The Quality of Sleep on the First Day after TACE Treatment
Description
The Richards-Campbell Sleep Questionnaire (RCSQ) is assessed by the quality of patients' sleep quality.0~25 points indicate poor sleep quality;76~100 points indicate good sleep quality (0-100, 0 represents the worst sleep quality; 100 represents the best sleep quality ;higher scores mean a better outcome)
Time Frame
From the first day after TACE treatment to the second day after TACE treatment
Title
Adverse Reaction
Description
Adverse reaction is recorded according to follow-up visits after TACE treatment
Time Frame
From 0 to 48 hours after the beginning of TACE operation
Title
Degree of Satisfaction
Description
Degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction;higher scores mean a better outcome)
Time Frame
From 0 to 24 hours after the beginning of TACE operation
Title
Quality-of-Life Assessment at the the beginning of TACE operation
Description
Quality-of-life contains patients' quality of sleep,fatigue, spiritual well-being, and appetite.The scores were categorized as follows: 1,worst;2,bad;3, mild;4, normal;5,very good.
Time Frame
From the beginning of TACE operation to 0 hour after the beginning of TACE operation
Title
Quality-of-Life Assessment at 24hours after the beginning of TACE operation
Description
Quality-of-life contains patients' quality of sleep,fatigue, spiritual well-being, and appetite.The scores were categorized as follows: 1,worst;2,bad;3, mild;4, normal;5,very good.
Time Frame
From 0 to 24 hours after the beginning of TACE operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 80 Participate in this study and sign informed consent Voluntarily receive preoperative intravenous analgesia Patients receiving TACE treatment HCC (hepatocellular carcinoma)patients with primary liver cancer BCLC(Barcelona Clinic Liver Cancer) stage A-C, liver function A-B Exclusion Criteria: Patients who were unable to cooperate or refused to participate in the trial Pregnant women Patients with or having a history of serious mental disorders Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic / diastolic blood pressure more than 180/100mg) Patients with unstable angina pectoris or myocardial infarction within 6 months or congestive heart failure Patients with intracranial hypertension or glaucoma Patients with hyperthyroidism without treatment or insufficient treatment Patients with severe respiratory dysfunction Allergy or existing contraindication to chemotherapeutic drugs, opioids or ketamine drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duan Guang you, MD
Phone
18323376014
Ext
+86
Email
duangy@hospital.cqmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Da gang, MD
Phone
023 63693014
Ext
+86
Email
kuanrenlunli@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huang He, MD
Organizational Affiliation
The Second Affiliated Hospital, Chongqing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated Hospital, Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duan Guangyou, MD
Phone
18323376014
Ext
+86
Email
duangy@hospital.cqmu.edu.cn

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 Access Criteria
Within one year

Learn more about this trial

Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma

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