Fentanyl Background Infusion for Acute Postoperative Pain

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Analgesia Disorder

Intervention / Treatment
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* Other: FX2-2-2
* Other: D6-4-2
* Other: D8-4-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who had undergone patient-controlled analgesia (PCA) after hysterectomy Exclusion Criteria: neurologic disorders psychiatric disorders renal or hepatic disorders

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FX2-2-2<br>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 | Other: D6-4-2<br>* 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.<br>* Other names: decremantl PCA 6-4-2;Other: D8-4-2<br>* 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.<br>* Other names: decremental PCA 8-4-2;|
| Active Comparator: D6-4-2<br>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 decremental rates of 6.0 ml/hr (D6-4-2) during 1 hr, 4.0 ml/hr during 1 3 hr and 2.0 ml/hr during 3 24 hr, | Other: FX2-2-2<br>* 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.<br>* Other names: decremental PCA;Other: D8-4-2<br>* 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.<br>* Other names: decremental PCA 8-4-2;|
| Active Comparator: D8-4-2<br>Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at at the decremental rates of 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, | Other: FX2-2-2<br>* 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.<br>* Other names: decremental PCA;Other: D6-4-2<br>* 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.<br>* Other names: decremantl PCA 6-4-2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scores (VAS) | 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. | until post-operative 24 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, fentanyl, total intravenous anesthesia