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Completed

NCT Number: NCT01785823

Fentanyl Background Infusion for Acute Postoperative Pain

We investigated the efficacy and the safety of the pharmacokinetic model-based patient-controlled analgesia (PCA) regimens of fentanyl for postoperative analgesia after total intravenous anesthesia (TIVA).

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Key information

Conditions

Analgesia Disorder Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University School of Medicine

Suwon, Gyeongki-do, 443-721, South Korea

About this study

Infusions of fentanyl (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr, or at the decremental rates of 6.0 ml/hr or 8.0 ml/hr during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who had undergone patient-controlled analgesia (PCA) after hysterectomy

Exclusion criteria

  • neurologic disorders
  • psychiatric disorders
  • renal or hepatic disorders

Treatment and study plan

FX2-2-2

Other

Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.

Other names: decremental PCA

D6-4-2

Other

Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.

Other names: decremantl PCA 6-4-2

D8-4-2

Other

Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.

Other names: decremental PCA 8-4-2

Primary outcomes

  1. visual analogue scores (VAS)

    Time frame: until post-operative 24 hrs

    The assessments of analgesia and patient condition were performed at the time points of immediate post-operative periods (1, 15, 30, 45, and 60 min) and post-operative 2, 3, 4, 6, 12 and 24 hr.

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

The Efficacy of the Time-scheduled Decremental Continuous Infusion of Fentanyl for Postoperative Patient-controlled Analgesia After Total Intravenous Anesthesia

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Feb 7, 2013
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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