AnalgesiaNCT05408052
Comparison of Standard Epidural and Dural Puncture Epidural Analgesia in Open Gynecological Surgery Techniques
A study testing Dural Puncture Epidural (DPE) and Standart Epidural in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effectiveness of standard epidural and dural puncture epidural analgesia techniques used under NOL guidance. The primary aim of this study was to evaluate the effect of NOL-guided antinociception on intraoperative total local anesthetic consumption during anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Dural Puncture Epidural (DPE) and Standart Epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 1 Jul 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III physical condition
- patients aged between 18-75 years
- elective surgeries under general anesthesia for gynecological procedures
- lower midline or Pfannenstiel incision
Who cannot join
- patients with classical contraindications to neuraxial procedures,
- morbidly obese (body mass index > 40 kg / m2),
- pregnant and lactating women
- hypersensitive or allergic to local anesthetic agents,
- abuse of drugs or alcohol in the past 6 months.
- chronic opioid use before surgery,
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- using chronic psychoactive drugs in the 90 days before surgery,
- patients with peripheral and central nervous system disease,
- preoperative hemodynamic compromise (patients with irregular sinus heart rhythm and pacemaker)
- patients using antimuscarinic, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents,
- patients with diabetes, severe lung and significant liver disease with increased bilirubin,
- operations that will take less than 2 hours
- MAP >160 mmHg or <60 mmHg, heart rate >90 beats/min or <45 beats/min on the day of surgery
- patients who do not want to participate in the study will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficiency of Standard Epidural and Dural Puncture Epidural Analgesia Techniques Guided by Nociception Level Index in Open Gynecological Surgery Under General Anesthesia: a Prospective Randomized Double-Blind Study
The aim of this study is to compare the effectiveness of standard epidural and dural puncture epidural analgesia techniques used under NOL guidance.
The primary aim of this study was to evaluate the effect of NOL-guided antinociception on intraoperative total local anesthetic consumption during anesthesia.
The secondary aim is to compare onset time, analgesia duration time, hemodynamic parameters, time to first postoperative analgesic requirement, and postoperative side effects.
Read the detailed description
This prospective randomized double-blind study was planned in 36 adult female patients aged 18-75 years, with ASA I-III, who underwent elective open gynecological surgery under general anesthesia with lower midline or Pfannenstiel incision after Ataturk University Medical Faculty Hospital ethics committee approval and written consent of the patients.
- Conditions
- Analgesia
- Being tested
- Dural Puncture Epidural (DPE), Standart Epidural
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural Puncture Epidural (DPE)Procedure or surgery
Using the 18G Tuohy needle in the sitting position, the epidural space will be determined from the L3-L4 or L4-L5 space using the loss-of-resistance method After Dural puncture will be performed using a 25G Whitacre needle from the Tuohy needle to patients in the DPE group and free CSF flow will be observed, but no medication will be applied to the subarachnoid space. Afterwards, epidural catheter will be placed and when the catheter is fixed, a test dose of 3 mL will be administered through the catheter to check for intravascular or subarachnoid catheter placement.
An epidural local anesthetic will be administered throughout the catheter for intraoperative analgesia at 0,1% (bupivacaine+fentanyl+ saline) concentration with the NoL monitor guidance.
Standart EpiduralProcedure or surgery
The neuraxial procedure will be performed in the sitting position using the 18G Tuohy needle, in the L3-L4 or L4-L5 range using the loss-of-resistance method.
The epidural catheter will be placed so that it remains 4 to 5 cm in the epidural space. After the catheter is fixed, a test dose of 3 mL will be administered through the catheter to check for intravascular or subarachnoid catheter placement.
An epidural local anesthetic will be administered throughout the catheter for intraoperative analgesia at 0,1% (bupivacaine+fentanyl+ saline) concentration with the NoL monitor guidance.
| Study group | Role | What they receive |
|---|---|---|
| Standard Epidural | Active comparator | Standard epidural technic will be applied before the anesthesia induction for perioperative analgesia Receives: Procedure: Standart Epidural |
| Dural Puncture Epidural (DPE) | Active comparator | Dural Puncture Epidural technic will be applied before the anesthesia induction for perioperative analgesia Receives: Procedure: Dural Puncture Epidural (DPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to compare the total amount of epidural local anesthetics consumed during the intraoperative period
The primary outcome is to compare the total amount of epidural local anesthetics (mg) consumed during the intraoperative period
Measured: intraoperative period
Secondary outcomes (1)
Our secondary aim is to compare onset time
Our secondary aim is to compare onset time
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start15 Aug 2022
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
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
- 36 participants (actual)
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
- NCT05408052
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/292
- Status last verified
- Feb 2025
- First submitted
- 31 May 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Standard Epidural and Dural Puncture Epidural Analgesia Techniques Guided by Nociception Level Index in Open Gynecological Surgery Under General Anesthesia: a Prospective Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT05408052
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/292
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 7 Jun 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.
The aim of this study is to compare the effectiveness of standard epidural and dural puncture epidural analgesia techniques used under NOL guidance.
The primary aim of this study was to evaluate the effect of NOL-guided antinociception on intraoperative total local anesthetic consumption during anesthesia.
The secondary aim is to compare onset time, analgesia duration time, hemodynamic parameters, time to first postoperative analgesic requirement, and postoperative side effects.
Detailed description
This prospective randomized double-blind study was planned in 36 adult female patients aged 18-75 years, with ASA I-III, who underwent elective open gynecological surgery under general anesthesia with lower midline or Pfannenstiel incision after Ataturk University Medical Faculty Hospital ethics committee approval and written consent of the patients.
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 |
|---|---|---|
| Standard Epidural | Active comparator | Procedure: Standart EpiduralStandard epidural technic will be applied before the anesthesia induction for perioperative analgesia |
| Dural Puncture Epidural (DPE) | Active comparator | Procedure: Dural Puncture Epidural (DPE)Dural Puncture Epidural technic will be applied before the anesthesia induction for perioperative analgesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III physical condition
- patients aged between 18-75 years
- elective surgeries under general anesthesia for gynecological procedures
- lower midline or Pfannenstiel incision
Key exclusion criteria (14 listed)
- patients with classical contraindications to neuraxial procedures,
- morbidly obese (body mass index > 40 kg / m2),
- pregnant and lactating women
- hypersensitive or allergic to local anesthetic agents,
- abuse of drugs or alcohol in the past 6 months.
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 |
|---|---|---|
| Dural Puncture Epidural (DPE)Using the 18G Tuohy needle in the sitting position, the epidural space will be determined from the L3-L4 or L4-L5 space using the loss-of-resistance method After Dural puncture will be performed using a 25G Whitacre needle from the Tuohy needle to patients in the DPE group and free CSF flow will be observed, but no medication will be applied to the subarachnoid space. Afterwards, epidural catheter will be placed and when the catheter is fixed, a test dose of 3 mL will be administered through the catheter to check for intravascular or subarachnoid catheter placement. An epidural local anesthetic will be administered throughout the catheter for intraoperative analgesia at 0,1% (bupivacaine+fentanyl+ saline) concentration with the NoL monitor guidance. | Procedure or surgery | Dural Puncture Epidural (DPE) |
| Standart EpiduralThe neuraxial procedure will be performed in the sitting position using the 18G Tuohy needle, in the L3-L4 or L4-L5 range using the loss-of-resistance method. The epidural catheter will be placed so that it remains 4 to 5 cm in the epidural space. After the catheter is fixed, a test dose of 3 mL will be administered through the catheter to check for intravascular or subarachnoid catheter placement. An epidural local anesthetic will be administered throughout the catheter for intraoperative analgesia at 0,1% (bupivacaine+fentanyl+ saline) concentration with the NoL monitor guidance. | Procedure or surgery | Standard Epidural |
Primary outcome
The primary outcome is to compare the total amount of epidural local anesthetics consumed during the intraoperative period
Time frame: intraoperative period
The primary outcome is to compare the total amount of epidural local anesthetics (mg) consumed during the intraoperative period
1 secondary outcome
Our secondary aim is to compare onset time
Time frame: intraoperative period
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 5 Feb 2025.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural Puncture Epidural (DPE) and Standart Epidural in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
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 4 inclusion and 14 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The primary outcome is to compare the total amount of epidural local anesthetics consumed during the intraoperative period (time frame: intraoperative period). 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 5 Feb 2025.