Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

Ablation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05848635
• Other study ID #: 20221209
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: Qianfoshan Hospital
• Contact: Xin Ye, graduate
• Phone: 18906417755
• Email: yexintaian[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ablation
• Multiple Pulmonary Nodules
• Pulmonary Nodule

Intervention

Drug:
• Hydromorphone Hydrochloride
Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation
• Morphine hydrochloride
Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of adverse reactions	cases of adverse reactions / total cases * 100%	perioperative period