Naldebain and Video-assisted Thoracoscopic Surgery

Kaohsiung Medical University

Status and phase: Enrolling; Phase 4

Conditions: Itching; Injection Site Reaction; Analgesia; Satisfaction, Patient; Nausea and Vomiting, Postoperative

Treatments: Drug: Nalbuphine Sebacate or Sesame oil (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT04962152

KMUHIRB-F(I)-20210087

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Group Naldebain

Experimental group

Description:

ultrasound-guided intramuscular injection of Naldebain 150mg after the induction anesthesia immediately

Treatment:

Drug: Nalbuphine Sebacate or Sesame oil (placebo)

Group Placebo

Placebo Comparator group

Description:

ultrasound-guided intramuscular injection of sesame oil (placebo) 2mL after the induction anesthesia immediately

Treatment:

Drug: Nalbuphine Sebacate or Sesame oil (placebo)