Postoperative Analgesic Effect of Nefopam

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02561494

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Drug: Nefopam Drug: Saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Intravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia.	Drug: Saline
Experimental: Nefopam Intravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia.	Drug: Nefopam

Arm

Intervention/Treatment

Placebo Comparator: Control

Intravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia.

Drug: Saline

Experimental: Nefopam

Intravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia.

Drug: Nefopam

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of	443-607

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyo-Seok Na, Doctor, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT02561494

Other Study ID Numbers:

Nefo_stomach op

First Posted:

Sep 28, 2015

Last Update Posted:

Oct 28, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Stomach Neoplasms

Nefopam

Study Results

No Results Posted as of Oct 28, 2016