Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia

NCT01732666 | Completed

• 1 other identifier: 4-2011-0883
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Laparoscopic Gastrectomy

Keywords

Opioid-induced hyperalgesia (OIH)

Outcome Measures

Primary Outcomes (1)

• 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).

  Postoperative 24 hr and 48 hr

Study Arms (3)

group L

PLACEBO COMPARATOR

receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.

Drug: low dose remifentanil

group H

PLACEBO COMPARATOR

100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.

Drug: high dose remifentanil

group N

EXPERIMENTAL

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.

Drug: Nefopam

Interventions

Nefopam DRUG

20 mg of Nefopam mixed in 100 ml of 0.9% saline IV immediately after induction of anesthesia.

group N

low dose remifentanil DRUG

100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.

group L

high dose remifentanil DRUG

100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.

group H

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing laparoscopic gastrectomy
• American Society of Anesthesiologists physical status I or II
• aged from 20 to 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Nefopam; Remifentanil

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2012
• First Posted: November 26, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

KR (1)