Back to resultsEffect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia
Primary Purpose
Patients Undergoing Laparoscopic Gastrectomy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nefopam
low dose remifentanil
high dose remifentanil
Sponsored by
About this trial
This is an interventional supportive care trial for Patients Undergoing Laparoscopic Gastrectomy focused on measuring Opioid-induced hyperalgesia (OIH)
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing laparoscopic gastrectomy
- American Society of Anesthesiologists physical status I or II
- aged from 20 to 65 years
Exclusion Criteria:
- Past history of chronic pain
- Drug or alcohol abuse
- Psychotic disorder
- Taking analgesics, anti-epileptics, and anti-depressants.
- Taking opioids within 24 hrs
- Renal disease
- Neuromuscular disease.
- Moderate to severe cardiovascular disease
- Pregnant or breast-feeding
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Arm Label
group L
group H
group N
Arm Description
receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
20mg of nefopam mixed in 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
Outcomes
Primary Outcome Measures
Hyperalgesic extent around surgical incision
The distance from the surgical incision to a point where patient does not feel pain when he gets stimuli with von Frey filament No.16 (122g/mm2).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01732666
Brief Title
Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was reported to occur after surgery when large amount of remifentanil was administered. On the other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to have analgesic and anti-hyperalgesic effect.
The investigators hypothesized that nefopam administration could prevent OIH or reduce the severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Undergoing Laparoscopic Gastrectomy
Keywords
Opioid-induced hyperalgesia (OIH)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group L
Arm Type
Placebo Comparator
Arm Description
receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
Arm Title
group H
Arm Type
Placebo Comparator
Arm Description
100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
Arm Title
group N
Arm Type
Experimental
Arm Description
20mg of nefopam mixed in 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
Intervention Type
Drug
Intervention Name(s)
Nefopam
Intervention Description
20 mg of Nefopam mixed in 100 ml of 0.9% saline IV immediately after induction of anesthesia.
Intervention Type
Drug
Intervention Name(s)
low dose remifentanil
Intervention Description
100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
Intervention Type
Drug
Intervention Name(s)
high dose remifentanil
Intervention Description
100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
Primary Outcome Measure Information:
Title
Hyperalgesic extent around surgical incision
Description
The distance from the surgical incision to a point where patient does not feel pain when he gets stimuli with von Frey filament No.16 (122g/mm2).
Time Frame
Postoperative 24 hr and 48 hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing laparoscopic gastrectomy
American Society of Anesthesiologists physical status I or II
aged from 20 to 65 years
Exclusion Criteria:
Past history of chronic pain
Drug or alcohol abuse
Psychotic disorder
Taking analgesics, anti-epileptics, and anti-depressants.
Taking opioids within 24 hrs
Renal disease
Neuromuscular disease.
Moderate to severe cardiovascular disease
Pregnant or breast-feeding
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
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Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia
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