Naldebain and Video-assisted Thoracoscopic Surgery

NCT ID: NCT04962152

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2024-05-07

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group Naldebain

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

Group Type: EXPERIMENTAL

Nalbuphine Sebacate or Sesame oil (placebo)

Intervention Type: DRUG

ultrasound-guided intramuscular injection after the induction of anesthesia immediately

Group Placebo

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

Group Type: PLACEBO_COMPARATOR

Nalbuphine Sebacate or Sesame oil (placebo)

Intervention Type: DRUG

ultrasound-guided intramuscular injection after the induction of anesthesia immediately

Interventions

Nalbuphine Sebacate or Sesame oil (placebo)

ultrasound-guided intramuscular injection after the induction of anesthesia immediately

Intervention Type: DRUG

Other Intervention Names

Naldebain ER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hung-Te Hsu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesiology, Kaohsiung Medical University Hospital

Locations

Department of Anesthesiology, Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung-Te Hsu, MD, PhD

Role: CONTACT

hdhsu1228@hotmail.com

+88673121101 ext. 7033

Hung-Te Hsu, MD, PhD

Role: CONTACT

hdhsu1228@yahoo.com.tw

+88673701260

Facility Contacts

Hung-Te Hsu, MD, PhD

Role: primary

hdhsu1228@hotmail.com

+88673121101 ext. 7033

References

Hsu HT, Ma CW, Chang PC, Kuo YW, Gau TP, Liu YW, Liu YC, Chou SH, Cheng KI. Effect of Dinalbuphine sebacate on postoperative multimodal analgesic strategy in video-assisted thoracoscopic surgery: a double-blind randomized controlled trial. BMC Anesthesiol. 2025 May 17;25(1):252. doi: 10.1186/s12871-025-03118-7.

Reference Type: DERIVED

PMID: 40382572 (View on PubMed)

Other Identifiers

KMUHIRB-F(I)-20210087

Identifier Type: -

Identifier Source: org_study_id