Postoperative Pain Management on Patients Undergoing Lung Tumor Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2026-05-30

Brief Summary

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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.

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Detailed Description

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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

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Postoperative Pain Lung Cancer Lung Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NALDEBAIN

Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group.

Dinalbuphine sebacate

Intervention Type DRUG

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 injectables

Intervention Type DRUG

Opioids, NSAIDs or acetamol will be administrated as need.

Enteral analgesics

Intervention Type DRUG

Opioids, NSAIDs or acetaminophen will be prescribed if necessary.

CONTROL

Patients receiving postoperative pain management without dinalbuphine sebacate will be allocated to CONTROL group.

Analgesic injectables

Intervention Type DRUG

Opioids, NSAIDs or acetamol will be administrated as need.

Enteral analgesics

Intervention Type DRUG

Opioids, NSAIDs or acetaminophen will be prescribed if necessary.

Interventions

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Dinalbuphine sebacate

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.

Intervention Type DRUG

Analgesic injectables

Opioids, NSAIDs or acetamol will be administrated as need.

Intervention Type DRUG

Enteral analgesics

Opioids, NSAIDs or acetaminophen will be prescribed if necessary.

Intervention Type DRUG

Other Intervention Names

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Naldebain A.I. E.A.

Eligibility Criteria

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Inclusion Criteria

1. aged above 18.
2. diagnosed as lung cancer.
3. planning to undergo primary, video-assisted thoracoscopic lung tumor resection.
4. American Society of Anesthesiology Physical Class 1\~3.

Exclusion Criteria

1. unable to take assessments of the endpoints.
2. having this surgery in an emergency.
3. surgery involving other orangs, such as esophagus and stomach.
4. severe abnormality of cardiac, hepatic, or renal function.
5. allergic to opioids.
6. allergic to NSAIDs.
7. diagnosed as chronic pain or chronic use of analgesics.
8. unsuitable for participation judged by investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No