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Trial Title:
Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled
NCT ID:
NCT05848635
Condition:
Pulmonary Nodule
Ablation
Conditions: Official terms:
Multiple Pulmonary Nodules
Morphine
Hydromorphone
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
Hydromorphone Hydrochloride
Description:
Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for
perioperative lung tumor ablation
Arm group label:
Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia
Other name:
Lung tumor ablation using hydromorphone hydrochloride
Intervention type:
Drug
Intervention name:
Morphine hydrochloride
Description:
Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative
lung tumor ablation
Arm group label:
Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia
Other name:
Lung tumor ablation using morphine hydrochloride
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
May 1, 2023
Completion date:
May 1, 2024
Lead sponsor:
Agency:
Qianfoshan Hospital
Agency class:
Other
Source:
Qianfoshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05848635
