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Comparison of Hemodynamic Stability and Pain Control

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ClinicalTrials.gov Identifier: NCT03966599
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hamidreza Shemshaki, Isfahan University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Percutaneous Nephrolithotomy Diagnostic Test: Pain Diagnostic Test: Hemodynamic changes Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : January 2, 2018
Actual Study Completion Date : February 3, 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lateral position
The patient position was changed to lateral during surgery
 Diagnostic Test: Pain
Patient's pain in order to VAS

Diagnostic Test: Hemodynamic changes
changes in hemodynamic states
Active Comparator: prone position
The patient position was changed to prone during surgery
 Diagnostic Test: Pain
Patient's pain in order to VAS

Diagnostic Test: Hemodynamic changes
changes in hemodynamic states


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. hemodynamic state [ Time Frame: at one year after surgery ]
    changes in blood pressure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966599


Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Study Director: Hamidreza Shemshaki, MD shahid beheshti university of medical sciences, tehran, iran
More Information
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Responsible Party: Hamidreza Shemshaki, Director, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03966599    
Other Study ID Numbers: 121333P
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hamidreza Shemshaki, Isfahan University of Medical Sciences:
Percutaneous Nephrolithotomy
Analgesic
hemodynamic status