Postoperative Pain Management on Patients Undergoing Lung Tumor Resection

April 30, 2024 updated by: Hsin-Yuan Fang, China Medical University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NALDEBAIN
Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group.
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.
Other Names:
  • Naldebain
Drug: Analgesic injectables
Opioids, NSAIDs or acetamol will be administrated as need.
Other Names:
  • A.I.
Drug: Enteral analgesics
Opioids, NSAIDs or acetaminophen will be prescribed if necessary.
Other Names:
  • E.A.
CONTROL
Patients receiving postoperative pain management without dinalbuphine sebacate will be allocated to CONTROL group.
Drug: Analgesic injectables
Opioids, NSAIDs or acetamol will be administrated as need.
Other Names:
  • A.I.
Drug: Enteral analgesics
Opioids, NSAIDs or acetaminophen will be prescribed if necessary.
Other Names:
  • E.A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 3 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2024

Primary Completion (Estimated)

March 2, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH-112-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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