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CompletedNCT05173337Updated Feb 14, 2023

Nefopam as a Multimodal Analgesia for Thoracic Surgery

An interventional study of Nefopam in Lung Cancer, sponsored by Kangbuk Samsung Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-14.

Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lung Cancer
03

In context

Lead sponsor

Kangbuk Samsung Hospital is the lead sponsor of 59 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • No intervention
    control group

    Nefopam will not be administered in this group.

  • Experimental
    nefopam group

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

    Drug: Nefopam

Interventions

  • DrugNefopam

    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.

06

What researchers measure

Primary outcomes

  1. Pain after 1 hour of surgery

    Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

    Time frame: 1 hour after surgery.

  2. Pain after 6 hour of surgery

    Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

    Time frame: 6 hours hours after surgery.

  3. Pain after 12 hour of surgery

    Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

    Time frame: 12 hours after surgery.

  4. Pain after 24 hour of surgery

    Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

    Time frame: 24 hours after surgery.

Secondary outcomes

  1. Patient-controlled analgesia use

    Fentanyl consumption administered thorough the patient-controlled analgesia machine.

    Time frame: 24 hours after surgery

  2. Rescue analgesics

    Additional analgesic use during postoperative period.

    Time frame: 24 hours after surgery.

07

Study locations

1 site
  • Eunah Cho
    Seoul, 03181, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05173337
Lead sponsor
Kangbuk Samsung Hospital
Responsible party
Eunah Cho, MD (Assistant Professor, Kangbuk Samsung Hospital) — Principal investigator
First posted
Dec 29, 2021
Start date
Dec 8, 2021
Primary completion
Sep 23, 2022
Completion
Sep 23, 2022
Last update
Feb 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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