AnalgesiaNCT05572164
Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index
A study testing TRADITIONAL EPIDURAL and DURAL PUNCTURE EPIDURAL in people with Analgesia, run by Ataturk University.
Trial summary
Primary aim of this study is to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia. Secondary aims are defining time interval between LA administration and SPI value dropping under 50 and hemodynamy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- TRADITIONAL EPIDURAL and DURAL PUNCTURE EPIDURAL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Dec 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-60
- ASA I-III
- grade I unilateral PNL
Who cannot join
- BMI > 40 kg/m2
- drug or alcohol abuse history in the last 6 mounts
- chronic opoid usage or had chronic pain longer than 6 weeks
- peripheral and central neurological disorders
- preoperative hemodynamic disorders
- irregular sinus rhythm and pace makers
Show all 12Show fewer
- diabetes, severe lung and major liver diseases with increasing biluribin
- use of anti-muscarinics, α2-adrenergic agonists, β1-adrenergic agonists, anti arrhythmic; who used chronic psychoactive drugs in last 90 days
- who are pregnant and breast feeding
- not willing to participate
- allergic or intolerant to any of the drugs in the study
- procedures that take less than 2 hours
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison On Efficiency Of Surgical Pleth Index-Guided Traditional Epidural And Dural Puncture Epidural Analgesia Techniques In Percutaneous Nephrolithotomy: A Randomised Double Blind Study
Primary aim of this study is to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia. Secondary aims are defining time interval between LA administration and SPI value dropping under 50 and hemodynamy. Tertiary results are total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)
- Conditions
- Analgesia
- Being tested
- TRADITIONAL EPIDURAL, DURAL PUNCTURE EPIDURAL
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRADITIONAL EPIDURALProcedure or surgery
epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia)
DURAL PUNCTURE EPIDURALProcedure or surgery
group on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia)
| Study group | Role | What they receive |
|---|---|---|
| TRADITIONAL EPIDURAL | Active comparator | standard epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia Receives: Procedure: TRADITIONAL EPIDURAL |
| DURAL PUNCTURE EPIDURAL | Active comparator | group on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia) Receives: Procedure: DURAL PUNCTURE EPIDURAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of local aneshesics
to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia
Measured: intraoperative
Secondary outcomes (2)
time interval and SPI value dropping
defining time interval between LA administration and SPI value dropping under 50 and hemodynamy
Measured: intraoperative
local anesthesic consumption
total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)
Measured: during the procedure/surgery and during 30 minutes of PACU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Dostbil, Ataturk University
- Investigators
- Ayşenur Dostbil, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572164
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/576
- Status last verified
- Oct 2022
- First submitted
- 13 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison On Efficiency Of Surgical Pleth Index-Guided Traditional Epidural And Dural Puncture Epidural Analgesia Techniques In Percutaneous Nephrolithotomy: A Randomised Double Blind Study
- ClinicalTrials.gov ID
- NCT05572164
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/576
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 7 Oct 2022 (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.
Primary aim of this study is to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia. Secondary aims are defining time interval between LA administration and SPI value dropping under 50 and hemodynamy. Tertiary results are total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRADITIONAL EPIDURAL | Active comparator | Procedure: TRADITIONAL EPIDURALstandard epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia |
| DURAL PUNCTURE EPIDURAL | Active comparator | Procedure: DURAL PUNCTURE EPIDURALgroup on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18-60
- ASA I-III
- grade I unilateral PNL
Key exclusion criteria (12 listed)
- BMI > 40 kg/m2
- drug or alcohol abuse history in the last 6 mounts
- chronic opoid usage or had chronic pain longer than 6 weeks
- peripheral and central neurological disorders
- preoperative hemodynamic disorders
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 |
|---|---|---|
| TRADITIONAL EPIDURALepidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia) | Procedure or surgery | TRADITIONAL EPIDURAL |
| DURAL PUNCTURE EPIDURALgroup on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia) | Procedure or surgery | DURAL PUNCTURE EPIDURAL |
Primary outcome
consumption of local aneshesics
Time frame: intraoperative
to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia
2 secondary outcomes
time interval and SPI value dropping
Time frame: intraoperative
local anesthesic consumption
Time frame: during the procedure/surgery and during 30 minutes of PACU stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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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.
Ayşenur Dostbil study director
Ataturk University
Questions about this trial
What is this clinical trial studying?
A study testing TRADITIONAL EPIDURAL and DURAL PUNCTURE EPIDURAL in people with Analgesia, run by Ataturk University.
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 12 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: status not confirmed, as of the sponsor's last update on 7 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Dostbil (+905333677796, adostbil@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of local aneshesics (time frame: intraoperative). 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 7 Oct 2022.