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Postoperative Analgesic Effect of Nefopam

Primary Purpose

Stomach Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nefopam
Saline
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stomach Neoplasms

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Nefopam

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day

Secondary Outcome Measures

Change of the pain score from postoperative 6 h to postoperative 5 day

Full Information

First Posted
August 2, 2015
Last Updated
October 27, 2016
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02561494
Brief Title
Postoperative Analgesic Effect of Nefopam
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Intravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia.
Arm Title
Nefopam
Arm Type
Experimental
Arm Description
Intravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia.
Intervention Type
Drug
Intervention Name(s)
Nefopam
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day
Time Frame
postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
Secondary Outcome Measure Information:
Title
Change of the pain score from postoperative 6 h to postoperative 5 day
Time Frame
postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
443-607
Country
Korea, Republic of

12. IPD Sharing Statement

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Postoperative Analgesic Effect of Nefopam

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