Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

Phase 4

Not yet recruiting

• Conditions: Ablation; Pulmonary Nodule
• Interventions: Drug: Hydromorphone Hydrochloride; Drug: Morphine hydrochloride

• Registration Number: NCT05848635
• Lead Sponsor: Qianfoshan Hospital

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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-09
• Study First Submitted QC: 2023-04-28
• Last Update Submitted: 2023-04-28
• Study Start: 2023-05-01
• Study First Posted: 2023-05-08
• Last Update Posted: 2023-05-08
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia	Hydromorphone Hydrochloride	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	Morphine hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of adverse reactions	perioperative period	cases of adverse reactions / total cases \* 100%