Comparison of Hemodynamic Stability and Pain Control

NCT ID: NCT03966599

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2018-02-03

Brief Summary

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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

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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.

Conditions

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Percutaneous Nephrolithotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lateral position

The patient position was changed to lateral during surgery

Group Type ACTIVE_COMPARATOR

Pain

Intervention Type DIAGNOSTIC_TEST

Patient's pain in order to VAS

Hemodynamic changes

Intervention Type DIAGNOSTIC_TEST

changes in hemodynamic states

prone position

The patient position was changed to prone during surgery

Group Type ACTIVE_COMPARATOR

Pain

Intervention Type DIAGNOSTIC_TEST

Patient's pain in order to VAS

Hemodynamic changes

Intervention Type DIAGNOSTIC_TEST

changes in hemodynamic states

Interventions

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Pain

Patient's pain in order to VAS

Intervention Type DIAGNOSTIC_TEST

Hemodynamic changes

changes in hemodynamic states

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Shemshaki

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hamidreza Shemshaki, MD

Role: STUDY_DIRECTOR

shahid beheshti university of medical sciences, tehran, iran

Other Identifiers

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121333P

Identifier Type: -

Identifier Source: org_study_id

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