Pulmonary Nodule, Ablation
Conditions
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.
Interventions
Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation
Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation
Sponsors
Qianfoshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions | perioperative period | cases of adverse reactions / total cases \* 100% |
Contacts
Primary ContactXin Ye, graduate
Backup ContactZhiGang Wei, doctorate
Outcome results
None listed