Postoperative Pain Management on Patients Undergoing Lung Tumor Resection

Not yet recruiting

• Conditions: Postoperative Pain; Lung Tumor; Lung Cancer
• Interventions: Drug: Dinalbuphine sebacate; Drug: Analgesic injectables; Drug: Enteral analgesics

• Registration Number: NCT06397807
• Lead Sponsor: China Medical University Hospital

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.

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03
• Study Start: 2024-05-31
• Primary Completion: 2026-03-02
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NALDEBAIN	Dinalbuphine sebacate	Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group.
NALDEBAIN	Enteral analgesics	Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group.
CONTROL	Analgesic injectables	Patients receiving postoperative pain management without dinalbuphine sebacate will be allocated to CONTROL group.
CONTROL	Enteral analgesics	Patients receiving postoperative pain management without dinalbuphine sebacate will be allocated to CONTROL group.
NALDEBAIN	Analgesic injectables	Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group.

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity	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.

Secondary Outcome Measures

Name	Time	Method
Consumption of analgesics	Within 7 days after surgery	The mean total consumption of analgesics during the hospital stay after delivery.
GAD-7	At baseline, 7 days and 3 months after surgery	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.
QoR-15	At baseline, 7 days and 3 months after surgery	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).