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Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer

Primary Purpose

Oxycodone

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Oxycodone 1mg/kg
Oxycodone 1.5mg/kg
Sufentanil
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oxycodone focused on measuring Oxycodone, Postoperative analgesia, lung cancer, thoracic paravertebral nerve block

Eligibility Criteria

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

Inclusion Criteria: Male or female, age > 60 years Patients undergoing thoracoscopic lobectomy ASA (American Academy of Anesthesiologists) Grades I-III There were no obvious abnormalities in heart, liver, and kidney function Sign the informed consent form for this clinical study Exclusion Criteria: History of oxycodone or sufentanil allergy Renal or hepatic dysfunction History of drug or alcohol abuse Psychiatric disorders: schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis Those who have difficulty communicating due to coma, severe dementia, speech barrier, or those who cannot cooperate due to other diseases. People with head trauma or other brain diseases -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Test group 1(OCA group)

    Test group 2(OCB group)

    Control group(SF group)

    Arm Description

    Outcomes

    Primary Outcome Measures

    The main indicators were NRS scores at rest and cough at 24 h postoperatively.
    NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.

    Secondary Outcome Measures

    Time to double-lumen tracheal extraction
    Time to double-lumen tracheal extraction
    NRS score at rest and cough
    NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.
    sedation score (Ramsay sedation score)
    The Ramsay sedation score is the most widely used sedation scoring criterion in clinical practice. It is divided into six levels, reflecting three levels of wakefulness and three levels of sleep. The higher the level, the deeper the level of sedation.
    sufentanil consumption
    sufentanil consumption
    oxycodone consumption
    oxycodone consumption
    analgesic pump compressions
    analgesic pump compressions
    additional analgesic doses
    additional analgesic doses
    incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin
    incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin
    gastrointestinal recovery (exhaust time)
    gastrointestinal recovery (exhaust time)
    laboratory results of C-reactive protein 1 day before and after surgery
    laboratory results of C-reactive protein 1 day before and after surgery
    laboratory results of interleukin-6 laboratory test 1 day before and after surgery
    laboratory results of interleukin-6 laboratory test 1 day before and after surgery

    Full Information

    First Posted
    February 14, 2023
    Last Updated
    February 15, 2023
    Sponsor
    Qianfoshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05742256
    Brief Title
    Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer
    Official Title
    Effect of Oxycodone Combined With Ultrasound Guided Thoracic Paravertebral Nerve Block on Postoperative Analgesia in Patients With Lung Cancer Undergoing Thoracoscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Qianfoshan Hospital

    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
    In this study, the effect of oxycodone combined with ultrasound-guided paravertebral nerve block on the postoperative analgesic effect of thoracoscopic lung cancer was investigated, and the effect and reasonable dose of oxycodone were explored, which provided a reference for the clinical multimodal analgesia after thoracoscopic lung cancer surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oxycodone
    Keywords
    Oxycodone, Postoperative analgesia, lung cancer, thoracic paravertebral nerve block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    159 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test group 1(OCA group)
    Arm Type
    Experimental
    Arm Title
    Test group 2(OCB group)
    Arm Type
    Experimental
    Arm Title
    Control group(SF group)
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Oxycodone 1mg/kg
    Other Intervention Name(s)
    Oxycodone
    Intervention Description
    Test group 1 (OCA group):oxycodone 1mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml
    Intervention Type
    Drug
    Intervention Name(s)
    Oxycodone 1.5mg/kg
    Intervention Description
    Test group 2 (OCB group): oxycodone 1.5mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml.
    Intervention Type
    Drug
    Intervention Name(s)
    Sufentanil
    Intervention Description
    Control group (SF group): sufentanil 2ug/kg + flurbiprofen + ondansetron 16mg + 0.9% normal saline diluted to 100ml.
    Primary Outcome Measure Information:
    Title
    The main indicators were NRS scores at rest and cough at 24 h postoperatively.
    Description
    NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.
    Time Frame
    at 24h after surgery
    Secondary Outcome Measure Information:
    Title
    Time to double-lumen tracheal extraction
    Description
    Time to double-lumen tracheal extraction
    Time Frame
    Within two hours after surgery
    Title
    NRS score at rest and cough
    Description
    NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.
    Time Frame
    at 2h , 4h, 12h, 48h after surgery
    Title
    sedation score (Ramsay sedation score)
    Description
    The Ramsay sedation score is the most widely used sedation scoring criterion in clinical practice. It is divided into six levels, reflecting three levels of wakefulness and three levels of sleep. The higher the level, the deeper the level of sedation.
    Time Frame
    at 2 h , 4 h , 12 h ,24 h,48 h postoperatively
    Title
    sufentanil consumption
    Description
    sufentanil consumption
    Time Frame
    Within 48 hours after surgery
    Title
    oxycodone consumption
    Description
    oxycodone consumption
    Time Frame
    Within 48 hours after surgery
    Title
    analgesic pump compressions
    Description
    analgesic pump compressions
    Time Frame
    Within 48 hours after surgery
    Title
    additional analgesic doses
    Description
    additional analgesic doses
    Time Frame
    Within 48 hours after surgery
    Title
    incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin
    Description
    incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin
    Time Frame
    Within 48 hours after surgery
    Title
    gastrointestinal recovery (exhaust time)
    Description
    gastrointestinal recovery (exhaust time)
    Time Frame
    Within 48 hours after surgery
    Title
    laboratory results of C-reactive protein 1 day before and after surgery
    Description
    laboratory results of C-reactive protein 1 day before and after surgery
    Time Frame
    Within 48 hours after surgery
    Title
    laboratory results of interleukin-6 laboratory test 1 day before and after surgery
    Description
    laboratory results of interleukin-6 laboratory test 1 day before and after surgery
    Time Frame
    Within 48 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, age > 60 years Patients undergoing thoracoscopic lobectomy ASA (American Academy of Anesthesiologists) Grades I-III There were no obvious abnormalities in heart, liver, and kidney function Sign the informed consent form for this clinical study Exclusion Criteria: History of oxycodone or sufentanil allergy Renal or hepatic dysfunction History of drug or alcohol abuse Psychiatric disorders: schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis Those who have difficulty communicating due to coma, severe dementia, speech barrier, or those who cannot cooperate due to other diseases. People with head trauma or other brain diseases -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pengcai Shi, Chief physician
    Phone
    13791126828
    Email
    shipc1997@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer

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