Comparison of Hemodynamic Stability and Pain Control

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

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 Overview

• Status: Completed
• Conditions: Percutaneous Nephrolithotomy
• Intervention / Treatment: Diagnostic test: Pain; Diagnostic test: Hemodynamic changes

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: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity in VAS score and need for analgesics in milligram	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.	at one year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemodynamic state	changes in blood pressure	at one year after surgery

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Study Director: Hamidreza Shemshaki, MD, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): January 2, 2018
• Study Completion (Actual): February 3, 2018

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Analgesic; Percutaneous Nephrolithotomy; hemodynamic status
• Other Study ID Numbers: 121333P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No