Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Nodule; Ablation
• Intervention / Treatment: Drug: Hydromorphone Hydrochloride; Drug: Morphine hydrochloride

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 Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xin Ye, graduate; Phone Number: 18906417755; Email: yexintaian@aliyun.com
• Study Contact Backup: Name: ZhiGang Wei, doctorate; Phone Number: 18615287195

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Hydromorphone Hydrochloride; Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation; Other Names: Lung tumor ablation using hydromorphone hydrochloride
Active Comparator: 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.	Drug: Morphine hydrochloride; Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation; Other Names: Lung tumor ablation using morphine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions	cases of adverse reactions / total cases * 100%	perioperative period

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Study Director: Xin Ye, graduate, head of intervention department

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 9, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Hydromorphone
• Other Study ID Numbers: 20221209

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No