Comparison of Hemodynamic Stability and Pain Control

Percutaneous Nephrolithotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966599
• Other study ID #: 121333P
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: February 3, 2018

Study information

• Verified date: May 2019
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 3, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Percutaneous Nephrolithotomy

Intervention

Diagnostic Test:
• Pain
Patient's pain in order to VAS
• Hemodynamic changes
changes in hemodynamic states

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	hemodynamic state	changes in blood pressure	at one year after surgery