Postoperative Pain Management on Patients Undergoing Lung Tumor Resection

Lung Cancer Clinical Trial

Official title:

Postoperative Pain Management on Patients Undergoing Video-assisted Thoracoscopic (VATS) Lung Tumor Resection: a Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397807
• Other study ID #: CMUH-112-01
• Status: Not yet recruiting
• Start date: May 31, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: April 2024
• Source: China Medical University Hospital
• Contact: Po-Han Li
• Phone: +886-4-22052121
• Email: bryan21825114[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 30, 2026
• Est. primary completion date: March 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Lung Tumor
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• 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.
• Analgesic injectables
Opioids, NSAIDs or acetamol will be administrated as need.
• Enteral analgesics
Opioids, NSAIDs or acetaminophen will be prescribed if necessary.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Consumption of analgesics	The mean total consumption of analgesics during the hospital stay after delivery.	Within 7 days after surgery
Secondary	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.	At baseline, 7 days and 3 months after surgery
Secondary	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).	At baseline, 7 days and 3 months after surgery