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Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

Primary Purpose

Pulmonary Nodule, Ablation

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Hydromorphone Hydrochloride
Morphine hydrochloride
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Nodule

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Voluntarily attend and sign the informed consent form in person; Patients undergoing selective pulmonary tumor ablation; The Eastern Collaborative Oncology Group (ECOG) defines an activity status score of 2 or less; The estimated survival time is more than 3 months; Age 18-80, both sexes. Exclusion Criteria: Severe coagulation dysfunction that cannot be corrected; History of severe cardio-cerebrovascular and respiratory diseases; Patients allergic to test drugs or contrast media; Patients with opioid addiction; Patients with cognitive dysfunction; Participated in other clinical investigators within three months; Investigators or their family members directly involved in the trial; Those who are deemed unfit to participate in the study by the investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia

    Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia

    Arm Description

    Premedication:hydromorphone is started 15min before surgery with a single subcutaneous injection of 2mg. Intraoperative administration:NRS（Numeric Rating Scale）≥7 during operation, 2mg hydromorphone is injected intravenously and slowly pushed for 2-3 minutes. Postoperative administration:The drug is administered as needed according to the patient's postoperative pain, 2mg/time.

    Premedication:morphine is started 15min before surgery with a single subcutaneous injection of 10mg. Intraoperative administration:NRS（Numeric Rating Scale）≥7 during operation, 10mg morphine is injected intravenously and slowly pushed for 2-3 minutes. Postoperative administration:The drug is administered as needed according to the patient's postoperative pain, 10mg/time.

    Outcomes

    Primary Outcome Measures

    Analgesic efficiency
    effective cases / total cases * 100%. The NRS（Numeric Rating Scale） score ≤3 at all evaluation time points is considered as effective analgesia.

    Secondary Outcome Measures

    Incidence of adverse reactions
    cases of adverse reactions / total cases * 100%

    Full Information

    First Posted
    April 9, 2023
    Last Updated
    April 28, 2023
    Sponsor
    Qianfoshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05848635
    Brief Title
    Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled
    Official Title
    Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled ：A Randomized, Parallel Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    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
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This randomized, parallel controlled, single blind trial is designed to evaluate the efficacy and safety of hydromorphone versus morphine for perioperative analgesia in lung tumor ablation.
    Detailed Description
    Although the consensus of relevant guidelines and clinical studies recommend the use of opioids for perioperative analgesia in pulmonary tumor ablation surgery, there is a lack of specific analgesic programs for clinical reference. In view of the advantages of clinical application of hydromorphone and the lack of evidence for its application in perioperative analgesia of pulmonary tumor ablation, this study aims to explore the efficacy and safety of hydromorphone in perioperative analgesia of pulmonary tumor ablation, and provide some reference and suggestions for perioperative analgesia of pulmonary tumor ablation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Nodule, Ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia
    Arm Type
    Experimental
    Arm Description
    Premedication:hydromorphone is started 15min before surgery with a single subcutaneous injection of 2mg. Intraoperative administration:NRS（Numeric Rating Scale）≥7 during operation, 2mg hydromorphone is injected intravenously and slowly pushed for 2-3 minutes. Postoperative administration:The drug is administered as needed according to the patient's postoperative pain, 2mg/time.
    Arm Title
    Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia
    Arm Type
    Active Comparator
    Arm Description
    Premedication:morphine is started 15min before surgery with a single subcutaneous injection of 10mg. Intraoperative administration:NRS（Numeric Rating Scale）≥7 during operation, 10mg morphine is injected intravenously and slowly pushed for 2-3 minutes. Postoperative administration:The drug is administered as needed according to the patient's postoperative pain, 10mg/time.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydromorphone Hydrochloride
    Other Intervention Name(s)
    Lung tumor ablation using hydromorphone hydrochloride
    Intervention Description
    Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine hydrochloride
    Other Intervention Name(s)
    Lung tumor ablation using morphine hydrochloride
    Intervention Description
    Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation
    Primary Outcome Measure Information:
    Title
    Analgesic efficiency
    Description
    effective cases / total cases * 100%. The NRS（Numeric Rating Scale） score ≤3 at all evaluation time points is considered as effective analgesia.
    Time Frame
    The analgesia is evaluated at 1 hour before surgery, 5 minutes after the beginning of ablation
    Secondary Outcome Measure Information:
    Title
    Incidence of adverse reactions
    Description
    cases of adverse reactions / total cases * 100%
    Time Frame
    perioperative period

    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: Voluntarily attend and sign the informed consent form in person; Patients undergoing selective pulmonary tumor ablation; The Eastern Collaborative Oncology Group (ECOG) defines an activity status score of 2 or less; The estimated survival time is more than 3 months; Age 18-80, both sexes. Exclusion Criteria: Severe coagulation dysfunction that cannot be corrected; History of severe cardio-cerebrovascular and respiratory diseases; Patients allergic to test drugs or contrast media; Patients with opioid addiction; Patients with cognitive dysfunction; Participated in other clinical investigators within three months; Investigators or their family members directly involved in the trial; Those who are deemed unfit to participate in the study by the investigator.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xin Ye, graduate
    Phone
    18906417755
    Email
    yexintaian@aliyun.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    ZhiGang Wei, doctorate
    Phone
    18615287195
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xin Ye, graduate
    Organizational Affiliation
    head of intervention department
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

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