The Comparison of Postoperative Pain After Lumbar Fusion Surgery in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment

Study Overview
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Brief Summary
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The postoperative pain of lumbar fusion surgery is very severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The most common pain control method of this surgery is the intravenous (IV) PCA. but, if it is relatively insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce the pain intensity effectively. Consequently, it may result in the a lot of rescue analgesics requirement, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. In addition, the patient's satisfaction to the PCA may be low compared with that of expected. For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. Therefore, this PCA device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. However, since there are few studies related to this new mode of PCA, more research is needed in patients with postoperative pain.

Official Title
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The Comparison of Postoperative Pain After Lumbar Fusion Surgery in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment

Conditions
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Back Pain, Fusion of Spine, Lumbar Region, Spinal Stenosis

Intervention / Treatment
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* Other: Optimizing basal infusion (B.I)
* Other: Conventional PCA mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects who undergoing lumbar fusion surgery ASA class Ⅰ-Ⅲ Written consents obtained to participate voluntarily in this clinical trial Exclusion Criteria: Sudden change of surgical plan Patients who have the hypersensitivity to the pain killers including narcotics Patients who are unable to express the degree of pain

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional PCA mode<br>(Mode setting; total volume: 140 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 15 minutes) | Other: Conventional PCA mode<br>* Mode setting; total volume: 150 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 10 minutes<br>|
| Experimental: Optimizing B.I (New) PCA mode<br>(Mode setting; total volume: 140 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 15 minutes) | Other: Optimizing basal infusion (B.I)<br>* In the intervention group, the optimizing B.I PCA mode will be setted. This mode is setted that the amount of administered drug per hour will be increased by 0.3 ml by pressing bolus button (The interval:   8 hr: 2 - 4 ml, 8-24 hr: 1 - 3 ml, 24 hours   : 0.5 - 2.5 ml). Conversely, if the bolus button is not used for 90 minutes, the administered amount of drug per hour is setted to be reduced by 0.1 ml, and the maximum (or minimum) allowable flow rate is 4 ml (or 0.5 ml).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the pain numeric rating scale | the pain scores will be measured by numeric rating scale range from 0 to 10. | At postoperative 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar fusion surgery, Patient Controlled Analgesia, Optimizing Basal Infusion Mode