Comparison of Hemodynamic Stability and Pain Control

NCT03966599 | Completed DMC

• 1 other identifier: 121333P
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Percutaneous Nephrolithotomy

Keywords

Percutaneous Nephrolithotomy; Analgesic; hemodynamic status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• hemodynamic state

  at one year after surgery

Study Arms (2)

Lateral position

ACTIVE COMPARATOR

The patient position was changed to lateral during surgery

Diagnostic Test: Pain; Diagnostic Test: Hemodynamic changes

prone position

ACTIVE COMPARATOR

The patient position was changed to prone during surgery

Diagnostic Test: Pain; Diagnostic Test: Hemodynamic changes

Interventions

Pain DIAGNOSTIC_TEST

Patient's pain in order to VAS

Lateral position; prone position

Hemodynamic changes DIAGNOSTIC_TEST

changes in hemodynamic states

Lateral position; prone position

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• those with coagulation defects,
• severe pain requiring more than one dose of fentanyl,
• considerable rise of blood pressure or heart rate during the operation.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

MeSH Terms

Interventions

Pain Measurement

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hamidreza Shemshaki, MD

  shahid beheshti university of medical sciences, tehran, iran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 29, 2019
• Study Start: April 1, 2016
• Primary Completion: January 2, 2018
• Study Completion: February 3, 2018
• Last Updated: May 29, 2019

Record last verified: 2019-05