Naldebain and Video-assisted Thoracoscopic Surgery

Phase 4

Recruiting

• Conditions: Nausea and Vomiting, Postoperative; Injection Site Reaction; Analgesia; Itching; Satisfaction, Patient
• Interventions: Drug: Nalbuphine Sebacate or Sesame oil (placebo)

• Registration Number: NCT04962152
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2021-07-05
• Study Start: 2021-07-07
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-14
• Status Verified: 2023-07
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-05-07
• Study Completion: 2024-05-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Placebo	Nalbuphine Sebacate or Sesame oil (placebo)	ultrasound-guided intramuscular injection of sesame oil (placebo) 2mL after the induction anesthesia immediately
Group Naldebain	Nalbuphine Sebacate or Sesame oil (placebo)	ultrasound-guided intramuscular injection of Naldebain 150mg after the induction anesthesia immediately

Primary Outcome Measures

Name	Time	Method
postoperative analgesic effect	the pain intensity was evaluated at 72 hours after surgery.	Use the visual analogue scale (VAS) score to assess the degree of pain after surgery

Trial Locations

Locations (1)

Department of Anesthesiology, Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung City, Taiwan