Pain, Postoperative
Conditions
Brief summary
In the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently.
Detailed description
In the case of the existing iv-pca, the analgesic drug was injected into the patient at a constant rate (ex. 1 ml / hr) and additional pain was controlled through the bolus dose (1 ml). As a result, the analgesic effect was insufficient, or the effect was excessive, causing side effects (nausea, vomiting, sedation, dizziness). Especially In spinal surgery, the degree of pain sharply decreases from day 1 to day 2. Classic iv-pca with constant infusion rate can not reflect this result. But in the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently. If the bolus button is not pressed for a certain period of time, it is expected that the injection rate will be reduced and the side effect caused by the analgesic agent will be decreased.
Interventions
The PCA regimen consisted of fentanyl 20 μg/kg and Ramosetron Hcl 0.3 mg (total volume including saline: 100 ml) and was programmed to deliver 1 ml /h as a background infusion and a bolus of 1.5 ml on-demand, with a 15 min lockout time. It can increment or decrement rate(0.2ml/hr) by press bolus button during a 48 h period
DEVICEConstant-rate Infusion mode
The PCA regimen consisted of fentanyl 20 μg/kg and Ramosetron Hcl 0.3 mg (total volume including saline: 100 ml) and was programmed to deliver 1 ml /h as a background infusion and a bolus of 1.5 ml on-demand, with a 15 min lockout time during a 48 h period
Sponsors
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Spine fusion surgery at Chung-Ang University Hospital with IV- PCA under general anesthesia
Exclusion criteria
* Unrecorded type of anesthetic agent * Denial to the study * Brain disorder * Cardiopulmonary disease * Psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demanded numbers of bolus button | Change from immediately to 24 hours after operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Change from immediately to 24 hours after operation | by Numerical Rating Scale(NRS) |
Countries
South Korea
Outcome results
None listed