Pulmonary NodulePhase 4NCT05848635
Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled
A Phase 4 study testing Hydromorphone Hydrochloride and Morphine hydrochloride in people with Pulmonary Nodule and Ablation, run by Qianfoshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodule, Ablation
- What is being tested?
- Hydromorphone Hydrochloride and Morphine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
ZhiGang Wei, doctorate contact
About this study
Official title: 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.
Read the 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
- Being tested
- Hydromorphone Hydrochloride, Morphine hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone HydrochlorideDrug
Also called Lung tumor ablation using hydromorphone hydrochloride
Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation
Morphine hydrochlorideDrug
Also called Lung tumor ablation using morphine hydrochloride
Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Morphine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficiency
effective cases / total cases * 100%. The NRS（Numeric Rating Scale） score ≤3 at all evaluation time points is considered as effective analgesia.
Measured: The analgesia is evaluated at 1 hour before surgery, 5 minutes after the beginning of ablation
Secondary outcomes (1)
Incidence of adverse reactions
cases of adverse reactions / total cases * 100%
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NoduleStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Ye, graduate, Study director, head of intervention department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848635
- Sponsor's protocol ID
- 20221209
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled ：A Randomized, Parallel Controlled Trial
- ClinicalTrials.gov ID
- NCT05848635
- Acronym / sponsor ID
- 20221209
- Conditions
- Pulmonary Nodule, Ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia | Experimental | Drug: Hydromorphone HydrochloridePremedication: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 | Active comparator | Drug: Morphine hydrochloridePremedication: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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone HydrochlorideAlso: Lung tumor ablation using hydromorphone hydrochlorideDrug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation | Drug | Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia |
| Morphine hydrochlorideAlso: Lung tumor ablation using morphine hydrochlorideDrug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation | Drug | Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia |
Primary outcome
Analgesic efficiency
Time frame: 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.
1 secondary outcome
Incidence of adverse reactions
Time frame: perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZhiGang Wei, doctorate contact
Xin Ye, graduate study director
head of intervention department
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone Hydrochloride and Morphine hydrochloride in people with Pulmonary Nodule and Ablation, run by Qianfoshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Ye, graduate (18906417755, yexintaian@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic efficiency (time frame: The analgesia is evaluated at 1 hour before surgery, 5 minutes after the beginning of ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.