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Comparison of Hemodynamic Stability and Pain Control

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03966599
Collaborator
(none)
50
Enrollment
2
Arms
22.1
Actual Duration (Months)

Study Details

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
  • Diagnostic Test: Pain
  • Diagnostic Test: Hemodynamic changes
 N/A

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

Study Type:
Interventional
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 :
Apr 1, 2016
Actual Primary Completion Date :
Jan 2, 2018
Actual Study Completion Date :
Feb 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 [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 [at one year after surgery]

    changes in blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • Isfahan University of Medical Sciences

Investigators

  • Study Director: Hamidreza Shemshaki, MD, shahid beheshti university of medical sciences, tehran, iran

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hamidreza Shemshaki, Director, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT03966599
Other Study ID Numbers:
  • 121333P
First Posted:
May 29, 2019
Last Update Posted:
May 29, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hamidreza Shemshaki, Director, Isfahan University of Medical Sciences
Percutaneous Nephrolithotomy
Analgesic
hemodynamic status

Study Results

No Results Posted as of May 29, 2019