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NCT Number: NCT03966599

Comparison of Hemodynamic Stability and Pain Control

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.

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Key information

Conditions

Percutaneous Nephrolithotomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain

Diagnostic Test

Patient's pain in order to VAS

Hemodynamic changes

Diagnostic Test

changes in hemodynamic states

Primary outcomes

  1. 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

  1. hemodynamic state

    Time frame: at one year after surgery

    changes in blood pressure

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 29, 2019
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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