Using Naldebain for pain relief after thoracoscopic surgery
To Explore the Effects of Naldebain Combined With Thoracic Paravertebral Block in Video-assisted Thoracoscopic Surgery.
This study is testing if a new pain medication called Naldebain can help people feel better after having video-assisted thoracoscopic surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital Academic / other |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT04962152 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Naldebain®, a long-acting analgesic, in combination with thoracic paravertebral block for managing postoperative pain in patients undergoing video-assisted thoracoscopic surgery (VATS). The approach aims to enhance pain control, as inadequate management of postoperative pain can lead to chronic pain and increased morbidity. Participants will receive either Naldebain or a placebo to assess the analgesic effects. The study focuses on a multimodal analgesic strategy to improve patient outcomes following surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 65 who require postoperative pain relief after thoracoscopic surgery.
Not a fit: Patients with communication disorders, coagulopathy, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve postoperative pain management for patients undergoing thoracoscopic surgery.
How similar studies have performed: Previous studies have shown positive outcomes with multimodal analgesic strategies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1) Subject's age: 20\~65 years old * 2) American Society of Anesthesiologists (ASA) Physical Status classification: I\~III * 3) Patients who need postoperative pain relief due to thoracoscopic surgery Exclusion Criteria: * 1. The patient suffers from a communication disorder * 2. The patient has coagulopathy * 3. Sick with obvious heart, lung, liver or kidney disease * 4. The patient's body mass index is less than 18.5 or greater than 35 * 5. Pregnant patients * 6. Patients who took opioids for more than three weeks before surgery * 7. Patients with contraindications to local anesthesia * 8. Patients with a history of chronic pain * 9. Patients with a history of drug allergy to Naldebain
Where this trial is running
Kaohsiung City
- Department of Anesthesiology, Kaohsiung Medical University Hospital — Kaohsiung City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hung-Te Hsu, MD, PhD — Department of anesthesiology, Kaohsiung Medical University Hospital
- Study coordinator: Hung-Te Hsu, MD, PhD
- Email: hdhsu1228@hotmail.com
- Phone: +88673121101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.