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Completed

NCT Number: NCT05173337

Nefopam as a Multimodal Analgesia for Thoracic Surgery

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eunah Cho

Seoul, 03181, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nefopam

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.

Primary outcomes

  1. Pain after 1 hour of surgery

    Time frame: 1 hour after surgery.

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

  2. Pain after 6 hour of surgery

    Time frame: 6 hours hours after surgery.

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

  3. Pain after 12 hour of surgery

    Time frame: 12 hours after surgery.

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

  4. Pain after 24 hour of surgery

    Time frame: 24 hours after surgery.

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

Secondary outcomes

  1. Patient-controlled analgesia use

    Time frame: 24 hours after surgery

    Fentanyl consumption administered thorough the patient-controlled analgesia machine.

  2. Rescue analgesics

    Time frame: 24 hours after surgery.

    Additional analgesic use during postoperative period.

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2021
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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