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Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05848635
Collaborator
(none)
88
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydromorphone Hydrochloride
  • Drug: Morphine hydrochloride
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled ：A Randomized, Parallel Controlled Trial
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia

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.

Drug: Hydromorphone Hydrochloride
Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation
Other Names:
  • Lung tumor ablation using hydromorphone hydrochloride

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

    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.

    Drug: Morphine hydrochloride
    Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation
    Other Names:
  • Lung tumor ablation using morphine hydrochloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Analgesic efficiency [The analgesia is evaluated at 1 hour before surgery, 5 minutes after the beginning of ablation]

      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

    1. Incidence of adverse reactions [perioperative period]

      cases of adverse reactions / total cases * 100%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Qianfoshan Hospital

    Investigators

    • Study Director: Xin Ye, graduate, head of intervention department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qianfoshan Hospital
    ClinicalTrials.gov Identifier:
    NCT05848635
    Other Study ID Numbers:
    • 20221209
    First Posted:
    May 8, 2023
    Last Update Posted:
    May 8, 2023
    Last Verified:
    Apr 1, 2023
    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
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules
    Morphine
    Hydromorphone

    Study Results

    No Results Posted as of May 8, 2023