Naldebain and Video-assisted Thoracoscopic Surgery

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962152
• Other study ID #: KMUHIRB-F(I)-20210087
• Status: Recruiting
• Phase: Phase 4
• Start date: July 7, 2021
• Est. completion date: May 7, 2024

Study information

• Verified date: July 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Hung-Te Hsu, MD, PhD
• Phone: +88673121101
• Email: hdhsu1228[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 7, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Nalbuphine Sebacate or Sesame oil (placebo)
ultrasound-guided intramuscular injection after the induction of anesthesia immediately

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, Kaohsiung Medical University Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.