Clinical trial
Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled ：A Randomized, Parallel Controlled Trial
Name
20221209
Description
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.
Trial arms
Trial start
2023-05-01
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Hydromorphone Hydrochloride
Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation
Arms:
Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia
Other names:
Lung tumor ablation using hydromorphone hydrochloride
Morphine hydrochloride
Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation
Arms:
Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia
Other names:
Lung tumor ablation using morphine hydrochloride
Size
88
Primary endpoint
Analgesic efficiency
The analgesia is evaluated at 1 hour before surgery, 5 minutes after the beginning of ablation
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 88, 'type': 'ESTIMATED'}}
Updated at
2023-05-08
1 organization
2 products
2 indications
Organization
Qianfoshan HospitalProduct
HydromorphoneIndication
Pulmonary NoduleIndication
AblationProduct
Morphine