Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01732666

Enrollment

Registered

2012-11-26

Start date

2012-05-31

Completion date

2012-09-30

Last updated

2014-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Laparoscopic Gastrectomy

Keywords

Opioid-induced hyperalgesia (OIH)

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.

Interventions

DRUGNefopam

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

DRUGlow dose remifentanil

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

DRUGhigh dose remifentanil

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026