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Clinical Trials/NCT03966599
NCT03966599CompletedNot 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 enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Primary Endpoint
pain intensity in VAS score and need for analgesics in milligram

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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.

Arms & Interventions

Lateral position

Active Comparator

The patient position was changed to lateral during surgery

Intervention: Pain (Diagnostic Test)

Lateral position

Active Comparator

The patient position was changed to lateral during surgery

Intervention: Hemodynamic changes (Diagnostic Test)

prone position

Active Comparator

The patient position was changed to prone during surgery

Intervention: Pain (Diagnostic Test)

prone position

Active Comparator

The patient position was changed to prone during surgery

Intervention: Hemodynamic changes (Diagnostic Test)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hamidreza Shemshaki

Director

Isfahan University of Medical Sciences

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