Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01732666
First received: November 18, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Patients Undergoing Laparoscopic Gastrectomy
Drug: Nefopam
Drug: low dose remifentanil
Drug: high dose remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Hyperalgesic extent around surgical incision [ Time Frame: Postoperative 24 hr and 48 hr ] [ Designated as safety issue: No ]
    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).


Enrollment: 25
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: group L
receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
Drug: low dose remifentanil
100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
Placebo Comparator: group H
100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
Drug: high dose remifentanil
100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
Experimental: group N
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
20 mg of Nefopam mixed in 100 ml of 0.9% saline IV immediately after induction of anesthesia.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732666

Locations
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01732666     History of Changes
Other Study ID Numbers: 4-2011-0883
Study First Received: November 18, 2012
Last Updated: February 17, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
Opioid-induced hyperalgesia (OIH)

Additional relevant MeSH terms:
Nefopam
Remifentanil
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014