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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia | Experimental | 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. |
|
| Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone Hydrochloride | Drug | Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions | cases of adverse reactions / total cases * 100% | perioperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Ye, graduate | Contact | 18906417755 | yexintaian@aliyun.com | |
| ZhiGang Wei, doctorate | Contact | 18615287195 |
| Name | Affiliation | Role |
|---|---|---|
| Xin Ye, graduate | head of intervention department | Study Director |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Morphine hydrochloride | Drug | Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation |
|
|
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |