NCT04962152

Naldebain and Video-assisted Thoracoscopic Surgery

To Explore the Effects of Naldebain Combined With Thoracic Paravertebral Block in Video-assisted Thoracoscopic Surgery.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the postoperative analgesic effect of combined use of Naldebain® and thoracic paravertebral block in thoracoscopic surgery

Detailed description

Video-assisted thoracoscopic surgery (VATS) can be associated with stronger postoperative pain than is commonly believed. Pain control after thoracic surgery is important because increased acute pain has been shown to increase the incidence of chronic pain, and untreated pain may lead to increased morbidity. It is generally accepted to introduce multimodal analgesic strategies based on regional blockade, opioids and non-steroidal anti-inflammatory drugs. Paravertebral block (PVB) involves the injection of local anesthetic into a wedge-shaped space lateral to the spinal nerves as they emerge from intervertebral foramina. It produces ipsilateral somatosensory and sympathetic nerve blockade effective for anesthesia as well as for management of pain of unilateral origin from the chest and abdomen. So far, thoracic paravertebral block (TPVB) is the most common technique used for patients undergoing VATS. TPVB may be useful after VATS because a single injection of local anesthesia may provide effective analgesia for the intense short-duration pain that patients experience. Nalbuphine sebacate (Naldebain®) is a long-acting prodrug of nalbuphine developed for meeting the unmet medical need of long-acting analgesics. It is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. The currently proposed clinical use of nalbuphine sebacate is a single dose of Naldebain® administered intramuscularly approximately 24 h prior to the planned surgery for pain relief. The purpose of this study is to determine the safety and efficacy of TPVB combined with a single dose of intramuscular Naldebain® administered preoperatively to patients scheduled to undergo VATS.

Conditions

• Analgesia
• Nausea and Vomiting, Postoperative
• Itching
• Injection Site Reaction
• Satisfaction, Patient

Interventions

Type	Name	Description
DRUG	Nalbuphine Sebacate or Sesame oil (placebo)	ultrasound-guided intramuscular injection after the induction of anesthesia immediately

Timeline

• Start date: 2021-07-07
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2021-07-14
• Last updated: 2024-03-21

Locations

1 site across 1 country: Taiwan