Postoperative Pain Management on Patients Undergoing Lung Tumor Resection

NCT06397807 | Not Yet Recruiting

• 1 other identifier: CMUH-112-01
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 3 days after surgery

Secondary Outcomes (3)

• Consumption of analgesics

  Within 7 days after surgery

• GAD-7

  At baseline, 7 days and 3 months after surgery

• QoR-15

  At baseline, 7 days and 3 months after surgery

Study Arms (2)

NALDEBAIN

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

Drug: Dinalbuphine sebacate; Drug: Analgesic injectables; Drug: Enteral analgesics

CONTROL

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

Drug: Analgesic injectables; Drug: Enteral analgesics

Interventions

Dinalbuphine sebacate 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.

Also known as: Naldebain

NALDEBAIN

Analgesic injectables DRUG

Opioids, NSAIDs or acetamol will be administrated as need.

Also known as: A.I.

CONTROL; NALDEBAIN

Enteral analgesics DRUG

Opioids, NSAIDs or acetaminophen will be prescribed if necessary.

Also known as: E.A.

CONTROL; NALDEBAIN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient scheduled to have video-assisted thoracoscopic lung tumor resection in China Medical University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Lung Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hsin-Yuan Fang

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Po-Han Li

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Kin-Shing Poon

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Hsiurong Liao

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Tzu-Min Huang

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Yu-Cheng Shen

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Han Li

CONTACT

+886-4-22052121; bryan21825114@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of China Medical University Hospital

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: May 31, 2024
• Primary Completion: March 2, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 3, 2024

Record last verified: 2024-04