Naldebain and Video-assisted Thoracoscopic Surgery

NCT04962152 | Unknown Phase 4

• 1 other identifier: KMUHIRB-F(I)-20210087
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (8)

• 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.

Study Arms (2)

Group Naldebain

EXPERIMENTAL

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

Drug: Nalbuphine Sebacate or Sesame oil (placebo)

Group Placebo

PLACEBO COMPARATOR

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

Drug: Nalbuphine Sebacate or Sesame oil (placebo)

Interventions

Nalbuphine Sebacate or Sesame oil (placebo) DRUG

ultrasound-guided intramuscular injection after the induction of anesthesia immediately

Also known as: Naldebain ER

Group Naldebain; Group Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Subject's age: 20\~65 years old
• \) American Society of Anesthesiologists (ASA) Physical Status classification: I\~III
• \) Patients who need postoperative pain relief due to thoracoscopic surgery

You may not qualify if:

• \. The patient suffers from a communication disorder
• \. The patient has coagulopathy
• \. Sick with obvious heart, lung, liver or kidney disease
• \. The patient's body mass index is less than 18.5 or greater than 35
• \. Pregnant patients
• \. Patients who took opioids for more than three weeks before surgery
• \. Patients with contraindications to local anesthesia
• \. Patients with a history of chronic pain
• \. Patients with a history of drug allergy to Naldebain

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Department of Anesthesiology, Kaohsiung Medical University Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 40382572 DERIVED

MeSH Terms

Conditions

Agnosia; Postoperative Nausea and Vomiting; Pruritus; Injection Site Reaction; Patient Satisfaction

Interventions

Sesame Oil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Extravasation of Diagnostic and Therapeutic Materials; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hung-Te Hsu, MD, PhD

  Department of anesthesiology, Kaohsiung Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Te Hsu, MD, PhD

CONTACT

+88673121101; hdhsu1228@hotmail.com

Hung-Te Hsu, MD, PhD

CONTACT

+88673701260; hdhsu1228@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 14, 2021
• Study Start: July 7, 2021
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: March 21, 2024

Record last verified: 2023-07

Locations

TW (1)