Postoperative PainNCT06397807
Postoperative Pain Management on Patients Undergoing Lung Tumor Resection
An observational study of Postoperative Pain and Lung Cancer, run by China Medical University Hospital.
Trial summary
Multimodal analgesia (MMA) is an essential part of Enhanced Recovery After Surgery (ERAS) protocol. The principle of MMA is to manage pain with analgesics of multiple classes acting on distinct target sites through different strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Lung Cancer, Lung Tumor
- What is being tested?
- Dinalbuphine sebacate, Analgesic injectables and Enteral analgesics
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2024to 30 May 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient scheduled to have video-assisted thoracoscopic lung tumor resection in China Medical University Hospital.
Who may be able to join
- aged above 18.
- diagnosed as lung cancer.
- planning to undergo primary, video-assisted thoracoscopic lung tumor resection.
- American Society of Anesthesiology Physical Class 1~3.
Who cannot join
- unable to take assessments of the endpoints.
- having this surgery in an emergency.
- surgery involving other orangs, such as esophagus and stomach.
- severe abnormality of cardiac, hepatic, or renal function.
- allergic to opioids.
- allergic to NSAIDs.
- diagnosed as chronic pain or chronic use of analgesics.
- unsuitable for participation judged by investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postoperative Pain Management on Patients Undergoing Video-assisted Thoracoscopic (VATS) Lung Tumor Resection: a Prospective Cohort Study
Multimodal analgesia (MMA) is an essential part of Enhanced Recovery After Surgery (ERAS) protocol. The principle of MMA is to manage pain with analgesics of multiple classes acting on distinct target sites through different strategies. MMA can reduce the adverse reaction caused by opioids and improve the quality of recovery from surgery. Inadequate postoperative pain management will increase the risk of complications, including pneumonia, deep vein thrombosis, infection, delayed surgical healing, and chronic postoperative pain.
Read the detailed description
This prospective, observational study is planned to investigate the efficacy of different MMA regimens conducting in our hospital. Patients undergoing video-assisted thoracoscopic (VATS) lung tumor resection will be invited to participate in the study and grouped based on the MMA regimens. Anxiety, quality of recovery, pain intensity will be evaluated pre- and post-operatively. Demographic data, surgery record, medicine record and postoperative complications will be gained from medical history system and analyzed.
- Conditions
- Postoperative Pain, Lung Cancer, Lung Tumor
- Being tested
- Dinalbuphine sebacate, Analgesic injectables, Enteral analgesics
- Keywords
- Video-assisted thoracoscopic (VATS) lung tumor resection, Naldebain, Dinalbuphine sebacate, Multimodal analgesia, Enhanced Recovery After Surgery, ERAS, MMA
- Medical subject headings
- Pain, Postoperative, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinalbuphine sebacateDrug
Also called Naldebain
Dinalbuphine sebacate (DS) is a long-acting injectable. With oil-based formulation, DS will slowly releases to blood vessel and be hydrolyzed to nalbuphine after intramuscularly injection. The analgesic effect lasts around 5 to 7 days.
Analgesic injectablesDrug
Also called A.I.
Opioids, NSAIDs or acetamol will be administrated as need.
Enteral analgesicsDrug
Also called E.A.
Opioids, NSAIDs or acetaminophen will be prescribed if necessary.
| Study group | Role | What they receive |
|---|---|---|
| NALDEBAIN | Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group. Receives: Drug: Dinalbuphine sebacate; Drug: Analgesic injectables; Drug: Enteral analgesics | |
| CONTROL | Patients receiving postoperative pain management without dinalbuphine sebacate will be allocated to CONTROL group. Receives: Drug: Analgesic injectables; Drug: Enteral analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Pain intensity is assessed by numerical rating scale (NRS) daily during hospital stay after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). The area under the curve of NRS are calculated.
Measured: Within 3 days after surgery
Secondary outcomes (3)
Consumption of analgesics
The mean total consumption of analgesics during the hospital stay after delivery.
Measured: Within 7 days after surgery
GAD-7
This self-administered patient questionnaire is used as a screening tool and severity measure for generalised anxiety disorder (GAD). Respondents are asked to rate each item for frequency of occurrence using a 4-point Likert scale (Not at all = 0, Several days = 1, More than half the days = 2, and Nearly every day = 3). All responses are summed to calculate the total GAD-7 score.
Measured: At baseline, 7 days and 3 months after surgery
QoR-15
The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 (extremely poor QoR) to 150 (excellent QoR).
Measured: At baseline, 7 days and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start31 May 2024 (estimated)
- Primary completion2 Mar 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by China Medical University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Yuan Fang, China Medical University Hospital
- Investigators
- Hsin-Yuan Fang, Principal investigator, China Medical University HospitalPo-Han Li, Principal investigator, China Medical University HospitalKin-Shing Poon, Principal investigator, China Medical University HospitalHsiurong Liao, Principal investigator, China Medical University HospitalTzu-Min Huang, Principal investigator, China Medical University HospitalYu-Cheng Shen, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397807
- Sponsor's protocol ID
- CMUH-112-01
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 3 May 2024
- 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 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management on Patients Undergoing Video-assisted Thoracoscopic (VATS) Lung Tumor Resection: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06397807
- Acronym / sponsor ID
- CMUH-112-01
- Conditions
- Postoperative Pain, Lung Cancer, Lung Tumor
- Keywords
- Video-assisted thoracoscopic (VATS) lung tumor resection, Naldebain, Dinalbuphine sebacate, Multimodal analgesia, Enhanced Recovery After Surgery, ERAS, MMA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 31 May 2024 (estimated)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 3 May 2024 (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.
Multimodal analgesia (MMA) is an essential part of Enhanced Recovery After Surgery (ERAS) protocol. The principle of MMA is to manage pain with analgesics of multiple classes acting on distinct target sites through different strategies. MMA can reduce the adverse reaction caused by opioids and improve the quality of recovery from surgery. Inadequate postoperative pain management will increase the risk of complications, including pneumonia, deep vein thrombosis, infection, delayed surgical healing, and chronic postoperative pain.
Detailed description
This prospective, observational study is planned to investigate the efficacy of different MMA regimens conducting in our hospital. Patients undergoing video-assisted thoracoscopic (VATS) lung tumor resection will be invited to participate in the study and grouped based on the MMA regimens. Anxiety, quality of recovery, pain intensity will be evaluated pre- and post-operatively. Demographic data, surgery record, medicine record and postoperative complications will be gained from medical history system and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NALDEBAIN | – | Drug: Dinalbuphine sebacate, Drug: Analgesic injectables, Drug: Enteral analgesicsPatients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group. |
| CONTROL | – | Drug: Analgesic injectables, Drug: Enteral analgesicsPatients receiving postoperative pain management without dinalbuphine sebacate will be allocated to CONTROL group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient scheduled to have video-assisted thoracoscopic lung tumor resection in China Medical University Hospital.
Key inclusion criteria (4 listed)
- aged above 18.
- diagnosed as lung cancer.
- planning to undergo primary, video-assisted thoracoscopic lung tumor resection.
- American Society of Anesthesiology Physical Class 1~3.
Key exclusion criteria (8 listed)
- unable to take assessments of the endpoints.
- having this surgery in an emergency.
- surgery involving other orangs, such as esophagus and stomach.
- severe abnormality of cardiac, hepatic, or renal function.
- allergic to opioids.
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 |
|---|---|---|
| Dinalbuphine sebacateAlso: NaldebainDinalbuphine sebacate (DS) is a long-acting injectable. With oil-based formulation, DS will slowly releases to blood vessel and be hydrolyzed to nalbuphine after intramuscularly injection. The analgesic effect lasts around 5 to 7 days. | Drug | NALDEBAIN |
| Analgesic injectablesAlso: A.I.Opioids, NSAIDs or acetamol will be administrated as need. | Drug | CONTROL, NALDEBAIN |
| Enteral analgesicsAlso: E.A.Opioids, NSAIDs or acetaminophen will be prescribed if necessary. | Drug | CONTROL, NALDEBAIN |
Primary outcome
Postoperative pain intensity
Time frame: Within 3 days after surgery
Pain intensity is assessed by numerical rating scale (NRS) daily during hospital stay after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). The area under the curve of NRS are calculated.
3 secondary outcomes
Consumption of analgesics
Time frame: Within 7 days after surgery
GAD-7
Time frame: At baseline, 7 days and 3 months after surgery
QoR-15
Time frame: At baseline, 7 days and 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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.
Hsin-Yuan Fang principal investigator
China Medical University Hospital
Po-Han Li principal investigator
China Medical University Hospital
Kin-Shing Poon principal investigator
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Lung Cancer, run by China Medical University 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 4 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 3 May 2024. 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.
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 Po-Han Li (+886-4-22052121 ext. 12939, bryan21825114@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: Within 3 days after surgery). 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 3 May 2024.