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Comparison of Hemodynamic Stability and Pain Control

Study Description
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
Layout table for study information
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
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
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
Layout table for eligibility information
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

Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Layout table for investigator information
Study Director: Hamidreza Shemshaki, MD shahid beheshti university of medical sciences, tehran, iran
Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE April 1, 2016
Actual Primary Completion Date January 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019) 		hemodynamic state [ Time Frame: at one year after surgery ]
changes in blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Hemodynamic Stability and Pain Control
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Percutaneous Nephrolithotomy
Intervention  ICMJE
  • Diagnostic Test: Pain
    Patient's pain in order to VAS
  • Diagnostic Test: Hemodynamic changes
    changes in hemodynamic states
Study Arms  ICMJE
  • Active Comparator: Lateral position
    The patient position was changed to lateral during surgery
    Interventions:
    • Diagnostic Test: Pain
    • Diagnostic Test: Hemodynamic changes
  • Active Comparator: prone position
    The patient position was changed to prone during surgery
    Interventions:
    • Diagnostic Test: Pain
    • Diagnostic Test: Hemodynamic changes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2019) 		50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 3, 2018
Actual Primary Completion Date January 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966599
Other Study ID Numbers  ICMJE 121333P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hamidreza Shemshaki, Isfahan University of Medical Sciences
Study Sponsor  ICMJE Isfahan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hamidreza Shemshaki, MD shahid beheshti university of medical sciences, tehran, iran
PRS Account Isfahan University of Medical Sciences
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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