Percutaneous NephrolithotomyNCT03966599
Comparison of Hemodynamic Stability and Pain Control
A study testing Pain and Hemodynamic changes in people with Percutaneous Nephrolithotomy, run by Isfahan University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- Pain and Hemodynamic changes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 3 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- those with coagulation defects,
- severe pain requiring more than one dose of fentanyl,
- considerable rise of blood pressure or heart rate during the operation.
About this study
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
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.
Read the 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.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- Pain, Hemodynamic changes
- Keywords
- Percutaneous Nephrolithotomy, Analgesic, hemodynamic status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainDiagnostic test
Patient's pain in order to VAS
Hemodynamic changesDiagnostic test
changes in hemodynamic states
| Study group | Role | What they receive |
|---|---|---|
| Lateral position | Active comparator | The patient position was changed to lateral during surgery Receives: Diagnostic Test: Pain; Diagnostic Test: Hemodynamic changes |
| prone position | Active comparator | The patient position was changed to prone during surgery Receives: Diagnostic Test: Pain; Diagnostic Test: Hemodynamic changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at one year after surgery
Secondary outcomes (1)
hemodynamic state
changes in blood pressure
Measured: at one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Apr 2016
- Primary completion2 Jan 2018
- Study completion3 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Shemshaki, Isfahan University of Medical Sciences
- Investigators
- Hamidreza Shemshaki, MD, Study director, shahid beheshti university of medical sciences, tehran, iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966599
- Sponsor's protocol ID
- 121333P
- Status last verified
- May 2019
- First submitted
- 17 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03966599
- Acronym / sponsor ID
- 121333P
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- Percutaneous Nephrolithotomy, Analgesic, hemodynamic status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 3 Feb 2018 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral position | Active comparator | Diagnostic Test: Pain, Diagnostic Test: Hemodynamic changesThe patient position was changed to lateral during surgery |
| prone position | Active comparator | Diagnostic Test: Pain, Diagnostic Test: Hemodynamic changesThe patient position was changed to prone during surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- those with coagulation defects,
- severe pain requiring more than one dose of fentanyl,
- considerable rise of blood pressure or heart rate during the operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PainPatient's pain in order to VAS | Diagnostic test | Lateral position, prone position |
| Hemodynamic changeschanges in hemodynamic states | Diagnostic test | Lateral position, prone position |
Primary outcome
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.
1 secondary outcome
hemodynamic state
Time frame: at one year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
Related trials for Percutaneous Nephrolithotomy
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Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
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Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
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Supine vs. Prone Mini-PCNL in Children
Kidney Calculi (or Renal Calculi / Nephrolithiasis), Supine Mini Percutaneous Nephrolithotomy
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Nephrostomy Tract Infiltration for Pain Control After PCNL
Postoperative Pain, Kidney Calculi
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Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy
Safety, Efficacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamidreza Shemshaki, MD study director
shahid beheshti university of medical sciences, tehran, iran
Questions about this trial
What is this clinical trial studying?
A study testing Pain and Hemodynamic changes in people with Percutaneous Nephrolithotomy, run by Isfahan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity in VAS score and need for analgesics in milligram (time frame: at one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.