Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled ：A Randomized, Parallel Controlled Trial

Conditions
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Pulmonary Nodule, Ablation

Intervention / Treatment
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* Drug: Hydromorphone Hydrochloride
* Drug: Morphine hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia<br>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<br>* Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation<br>* Other names: Lung tumor ablation using hydromorphone hydrochloride;|
| Active Comparator: Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia<br>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<br>* Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation<br>* Other names: Lung tumor ablation using morphine hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic efficiency | effective cases / total cases * 100%. The NRS（Numeric Rating Scale） score ≤3 at all evaluation time points is considered as effective analgesia. | The analgesia is evaluated at 1 hour before surgery, 5 minutes after the beginning of ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse reactions | cases of adverse reactions / total cases * 100% | perioperative period |