Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia

Not Applicable

Completed

• Conditions: Patients Undergoing Laparoscopic Gastrectomy
• Interventions: Drug: low dose remifentanil; Drug: high dose remifentanil; Drug: Nefopam

• Registration Number: NCT01732666
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2012-11-18
• Study First Submitted QC: 2012-11-23
• Study First Posted: 2012-11-26
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Patients undergoing laparoscopic gastrectomy
2. American Society of Anesthesiologists physical status I or II
3. aged from 20 to 65 years

Exclusion Criteria

1. Past history of chronic pain
2. Drug or alcohol abuse
3. Psychotic disorder
4. Taking analgesics, anti-epileptics, and anti-depressants.
5. Taking opioids within 24 hrs
6. Renal disease
7. Neuromuscular disease.
8. Moderate to severe cardiovascular disease
9. Pregnant or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group L	low dose remifentanil	receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
group H	high dose remifentanil	100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
group N	Nefopam	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.

Primary Outcome Measures

Name	Time	Method
Hyperalgesic extent around surgical incision	Postoperative 24 hr and 48 hr	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).

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of