Nefopam as a Multimodal Analgesia for Thoracic Surgery

Sponsor

Kangbuk Samsung Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05173337

Collaborator

(none)

Enrollment

Location

Arms

24.2

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Nefopam	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery

Actual Study Start Date :

Dec 8, 2021

Anticipated Primary Completion Date :

Dec 12, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Pain after 1 hour of surgery [1 hour after surgery.]
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
Pain after 6 hour of surgery [6 hours hours after surgery.]
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
Pain after 12 hour of surgery [12 hours after surgery.]
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
Pain after 24 hour of surgery [24 hours after surgery.]
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).

Secondary Outcome Measures

Patient-controlled analgesia use [24 hours after surgery]
Fentanyl consumption administered thorough the patient-controlled analgesia machine.
Rescue analgesics [24 hours after surgery.]
Additional analgesic use during postoperative period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eunah Cho	Seoul		Korea, Republic of	03181

Sponsors and Collaborators

Kangbuk Samsung Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eunah Cho, MD, Assistant Professor, Kangbuk Samsung Hospital

ClinicalTrials.gov Identifier:

NCT05173337

Other Study ID Numbers:

NEVATS2

First Posted:

Dec 29, 2021

Last Update Posted:

Dec 29, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nefopam

Study Results

No Results Posted as of Dec 29, 2021