Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

Qianfoshan Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Ablation; Pulmonary Nodule

Treatments: Drug: Hydromorphone Hydrochloride; Drug: Morphine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05848635

20221209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Hydromorphone Hydrochloride

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

Active Comparator group

Description:

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.

Treatment:

Drug: Morphine hydrochloride