NCT06176222

Brief Summary

The goal of this clinical trial is to investigate the effects of combined use of Naldebain® ER Injection and Precedex® in patients received video-assisted thoracoscopic surgery. The main questions it aims to answer are:

  • the pain intensity after surgery
  • the level of dizziness after surgery Participants will receice ultrasound-guided thoracic paravertebral nerve block, intramuscular Naldebain® ER injection and intravenous Precedex® infusion. If there is a comparison group: Researchers will compare experimental group with placebo group to see if pain and dizziness after surgery can reduced.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

December 28, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

December 19, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

December 10, 2023

Last Update Submit

December 10, 2023

Conditions

Acute Post Operative PainChronic Post Operative PainPostoperative Complications

Keywords

Multimodal AnalgesiaDinalbuphine SebacateDexmedetomidineVideo-Assisted Thoracic Surgery

Outcome Measures

Primary Outcomes (3)

  • poatoperative analgesic effect

    Use the numerical rating scale (NRS) score to ass the intensity of pain after surgery

    During the 60 minutes of rest in the PACU, the patient's pain intensity was assessed every fifteen minutes.

  • poatoperative analgesic effect

    Use the numerical rating scale (NRS) score to ass the intensity of pain after surgery

    the first morning and afternoon after surgery, and the second morning and afternoon after surgery

  • poatoperative analgesic effect

    Use the numerical rating scale (NRS) score to ass the intensity of pain after surgery

    the third day after surgery, the fourth day after surgery, the fifth day after surgery, and the sixth day after surgery

Study Arms (2)

Precedex Group

EXPERIMENTAL

Drug: PRECEDEX INJ★ 2ML Dosage form: 100 mcg/ml dexmedetomidine Dosage: 0.1\~0.4 mcg/kg/hr intravenous infusion Frequency and Duration: intrvenous infusion 12 hours after the surgery immediately

Drug: PRECEDEX INJ★ 2ML

Placebo Group

PLACEBO COMPARATOR

Drug: 0.9% Normal Sline Dosage: 0.1 ml/kg/hr intravenous infusion Frequency and Duration: intrvenous infusion 12 hours after the surgery immediately

Drug: Normal saline

Interventions

PRECEDEX INJ★ 2MLDRUG

patient received PRECEDEX INJ★ 2ML 0.1\~0.4 mcg/kg/hr intravenous infusion 12 hours after the surgery immediately

Also known as: Dexmedetomidine
Precedex Group
Normal salineDRUG

patient received Normal Saline 0.1 ml/kg/hr intravenous infusion 12 hours after the surgery immediately

Also known as: 0.9% Normal Saline
Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject's age: 18\~65 years old

You may not qualify if:

  • Patients who need postoperative pain relief due to thoracoscopic surgery
  • 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® ER Injection, COX2-inhibitor NSAIDs (such as parecoxib), or Precedex®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hung-Te Hsu

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

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

+88673121101hdhsu1228@hotmail.com

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

December 10, 2023

First Posted

December 19, 2023

Study Start

December 28, 2023

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

December 19, 2023

Record last verified: 2023-10

Locations

TW(1)