Comparison of Hemodynamic Stability and Pain Control

Not Applicable

Completed

• Conditions: Percutaneous Nephrolithotomy
• Interventions: Diagnostic Test: Pain; Diagnostic Test: Hemodynamic changes

• Registration Number: NCT03966599
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2018-01-02
• Study Completion: 2018-02-03
• Status Verified: 2019-05
• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-24
• Last Update Submitted: 2019-05-24
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prone position	Pain	The patient position was changed to prone during surgery
Lateral position	Pain	The patient position was changed to lateral during surgery
Lateral position	Hemodynamic changes	The patient position was changed to lateral during surgery
prone position	Hemodynamic changes	The patient position was changed to prone during surgery

Primary Outcome Measures

Name	Time	Method
pain intensity in VAS score and need for analgesics in milligram	at one year after surgery	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.

Secondary Outcome Measures

Name	Time	Method
hemodynamic state	at one year after surgery	changes in blood pressure