Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

NCT ID: NCT05848635

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-05-01

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.

Conditions

Pulmonary Nodule; Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia

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.

Group Type: EXPERIMENTAL

Hydromorphone Hydrochloride

Intervention Type: DRUG

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

Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia

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.

Group Type: ACTIVE_COMPARATOR

Morphine hydrochloride

Intervention Type: DRUG

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

Interventions

Hydromorphone Hydrochloride

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

Intervention Type: DRUG

Morphine hydrochloride

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

Intervention Type: DRUG

Other Intervention Names

Lung tumor ablation using hydromorphone hydrochloride; Lung tumor ablation using morphine hydrochloride

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Ye, graduate

Role: STUDY_DIRECTOR

head of intervention department

Central Contacts

Xin Ye, graduate

Role: CONTACT

yexintaian@aliyun.com

18906417755

ZhiGang Wei, doctorate

Role: CONTACT

18615287195

Other Identifiers

20221209

Identifier Type: -

Identifier Source: org_study_id