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Clinical Trials/NCT03966599
NCT03966599
Completed
Not Applicable

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

Isfahan University of Medical Sciences0 sites50 target enrollmentApril 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Percutaneous Nephrolithotomy
Sponsor
Isfahan University of Medical Sciences
Enrollment
50
Primary Endpoint
pain intensity in VAS score and need for analgesics in milligram
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
February 3, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hamidreza Shemshaki

Director

Isfahan University of Medical Sciences

Eligibility Criteria

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.

Outcomes

Primary Outcomes

pain intensity in VAS score and need for analgesics in milligram

Time Frame: 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 Outcomes

  • hemodynamic state(at one year after surgery)

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