Naldebain and Video-assisted Thoracoscopic Surgery

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hung-Te Hsu, MD, PhD; Phone Number: 7033 +88673121101; Email: hdhsu1228@hotmail.com
• Study Contact Backup: Name: Hung-Te Hsu, MD, PhD; Phone Number: +88673701260; Email: hdhsu1228@yahoo.com.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Recruiting
    • Department of Anesthesiology, Kaohsiung Medical University Hospital
    • Contact: Hung-Te Hsu, MD, PhD; Phone Number: 7033 +88673121101; Email: hdhsu1228@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Naldebain; ultrasound-guided intramuscular injection of Naldebain 150mg after the induction anesthesia immediately	Drug: Nalbuphine Sebacate or Sesame oil (placebo); ultrasound-guided intramuscular injection after the induction of anesthesia immediately; Other Names: Naldebain ER
Placebo Comparator: Group Placebo; ultrasound-guided intramuscular injection of sesame oil (placebo) 2mL after the induction anesthesia immediately	Drug: Nalbuphine Sebacate or Sesame oil (placebo); ultrasound-guided intramuscular injection after the induction of anesthesia immediately; Other Names: Naldebain ER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative analgesic effect	Use the visual analogue scale (VAS) score to assess the degree of pain after surgery	During the first one hour in the recovery room, the pain intensity was evaluated every 15 minutes.
postoperative analgesic effect	Use the visual analogue scale (VAS) score to assess the degree of pain after surgery	the pain intensity was evaluated at 3 hours after surgery.
postoperative analgesic effect	Use the visual analogue scale (VAS) score to assess the degree of pain after surgery	the pain intensity was evaluated at 6 hours after surgery.
postoperative analgesic effect	Use the visual analogue scale (VAS) score to assess the degree of pain after surgery	the pain intensity was evaluated at 12 hours after surgery.
postoperative analgesic effect	Use the visual analogue scale (VAS) score to assess the degree of pain after surgery	the pain intensity was evaluated at 24 hours after surgery.
postoperative analgesic effect	Use the visual analogue scale (VAS) score to assess the degree of pain after surgery	the pain intensity was evaluated at 36 hours after surgery.
postoperative analgesic effect	Use the visual analogue scale (VAS) score to assess the degree of pain after surgery	the pain intensity was evaluated at 48 hours after surgery.
postoperative analgesic effect	Use the visual analogue scale (VAS) score to assess the degree of pain after surgery	the pain intensity was evaluated at 72 hours after surgery.

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Hung-Te Hsu, MD, PhD, Department of Anesthesiology, Kaohsiung Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Estimated): May 7, 2024
• Study Completion (Estimated): May 7, 2024

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Drug-Related Side Effects and Adverse Reactions; Nausea; Extravasation of Diagnostic and Therapeutic Materials; Vomiting; Postoperative Nausea and Vomiting; Injection Site Reaction; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Nalbuphine
• Other Study ID Numbers: KMUHIRB-F(I)-20210087

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No