Postoperative Analgesic Effect of Nefopam

Stomach Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561494
• Other study ID #: Nefo_stomach op
• Status: Completed
• Phase: N/A
• First received: August 2, 2015
• Last updated: October 27, 2016
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (TIVA).

The investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following consumption of fentanyl during postoperative period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Early or advanced gastric cancer

Exclusion Criteria:

• Refusal

• Use of preoperative analgesic drugs

• Pregnancy

• Recurred gastric cancer

• Seizure

• Cardiac disease

• Monoamine oxidase inhibitor

• Urologic disease

• Previous intrabdominal surgery

• Body mass index > 30 or < 16

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• Nefopam

• Saline

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day		postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day	No
Secondary	Change of the pain score from postoperative 6 h to postoperative 5 day		postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day	No