Nefopam as a Multimodal Analgesia for Thoracic Surgery

NCT ID: NCT05173337

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-08

Study Completion Date

2022-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Acute postoperative pain after video-assisted thoracoscopic surgery is very severe. Because pain after thoracic surgery prevents early recovery, and increases postoperative complications, its is important to prevent pain after video-assisted thoracoscopic surgery. In the present study, we will evaluate whether nefopam reduces pain after video-assisted thoracoscopic surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

Nefopam will not be administered in this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

nefopam group

Intravenous nefopam 20 mg will be administered twice, immediately after induction of anesthesia and at the end of surgery.

Group Type EXPERIMENTAL

Nefopam

Intervention Type DRUG

Nefopam 20 mg is mixed to 100 mL of normal saline, and is infused intravenously over 15 minutes.

20 mg of nefopam is administered intravenously for two times, after induction and at the end of surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nefopam

Nefopam 20 mg is mixed to 100 mL of normal saline, and is infused intravenously over 15 minutes.

20 mg of nefopam is administered intravenously for two times, after induction and at the end of surgery.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patient scheduled for elective video-assisted thoracoscopic surgery
* American Society of Anesthesiologists physical grade I, II, III
* patient aged from 18 years old

Exclusion Criteria

* history of allergy in nonsteroidal anti-inflammatory drugs, or nefopam
* renal insufficiency
* liver insufficiency
* myocardial infarction
* glaucoma
* pregnant and lactating women at the time of surgery
* patient who did not consent to the use of patient-controlled analgesia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eunah Cho, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eunah Cho

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Ki HS, Shim JG, Choi HK, Ryu KH, Kang DY, Park J, Ahn JH, Lee SH, Cho EA. Nefopam as a multimodal analgesia in thoracoscopic surgery: a randomized controlled trial. J Thorac Dis. 2024 Jun 30;16(6):3644-3654. doi: 10.21037/jtd-24-30. Epub 2024 Jun 12.

Reference Type DERIVED
PMID: 38983158 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NEVATS2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.