Comparison of Hemodynamic Stability and Pain Control

Study Overview
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Brief Summary
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This study was designed to evaluate whether patient position (lateral vs. prone) has affect on the need for analgesia and onset of pain after surgery.

Detailed Description
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Percutaneous Nephrolithotomy is the preferred surgical treatment in many cases of kidney stones which is performed in different positions such as prone, lateral, and supine. However, we do not have enough evidence comparing prone and lateral positioning regarding the need for analgesia and onset of pain after surgery. This study was designed to evaluate whether patient position (lateral vs. prone) has affect on the need for analgesia and onset of pain after surgery.

Official Title
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Comparison of Hemodynamic Stability and Pain Control Between Two Anesthesia Positions of Lateral and Prone in Patients Undergoing Percutaneous Nephrolithotomy; a Randomized Controlled Trial Study

Conditions
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Percutaneous Nephrolithotomy

Intervention / Treatment
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* Diagnostic Test: Pain
* Diagnostic Test: Hemodynamic changes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria were age between 18-65 years, having kidney stones; consent for spinal anesthesia, ASA classes (American Society of Anesthesiologists class) of 1 and 2 (patients without any cardiovascular or respiratory disorders) superior and median ureter larger than 20 mm in diameter. Exclusion Criteria: those with coagulation defects, severe pain requiring more than one dose of fentanyl, considerable rise of blood pressure or heart rate during the operation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lateral position<br>The patient position was changed to lateral during surgery | Diagnostic Test: Pain<br>* Patient's pain in order to VAS<br>Diagnostic Test: Hemodynamic changes<br>* changes in hemodynamic states<br>|
| Active Comparator: prone position<br>The patient position was changed to prone during surgery | Diagnostic Test: Pain<br>* Patient's pain in order to VAS<br>Diagnostic Test: Hemodynamic changes<br>* changes in hemodynamic states<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity in VAS score and need for analgesics in milligram | determining pain with visual analogue scale (VAS) and need for analgesics (milligram) in lateral versus prone position. The visual analogue scale (VAS) is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optimal tool for describing pain severity or intensity. | at one year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic state | changes in blood pressure | at one year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Nephrolithotomy, Analgesic, hemodynamic status