Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

NCT05848635 | Unknown Phase 4

• 1 other identifier: 20221209
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Nodule; Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of adverse reactions

  perioperative period

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

Hydromorphone Hydrochloride DRUG

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

Also known as: Lung tumor ablation using hydromorphone hydrochloride

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

Morphine hydrochloride DRUG

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

Also known as: Lung tumor ablation using morphine hydrochloride

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Xin Ye, graduate

  head of intervention department

  STUDY DIRECTOR

Central Study Contacts

Xin Ye, graduate

CONTACT

18906417755; yexintaian@aliyun.com

ZhiGang Wei, doctorate

CONTACT

18615287195

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: May 8, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 8, 2023

Record last verified: 2023-04