Regional Anaesthesia in Cesarean OperationsNCT07295080
Comparison of Dural Puncture Epidural and Standard Epidural Anesthesia Techniques in Elective Cesarean Deliveries
A study testing Dural puncture epidural (DPE) anaesthesia and standart epidural anesthesia in people with Regional Anaesthesia in Cesarean Operations, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Neuraxial techniques are the most effective form of labor analgesia in contemporary obstetric anesthesia practice, predominantly through the use of epidural (EPL) and combined spinal-epidural (CSE) techniques. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Regional Anaesthesia in Cesarean Operations
- What is being tested?
- Dural puncture epidural (DPE) anaesthesia and standart epidural anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 May 2026
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women scheduled for elective cesarean delivery
- No comorbidities
- Age between 18-40 years
- Body mass index (BMI) < 35 kg/m²
- Term pregnancy ≥ 37 weeks
- No contraindications to neuraxial anesthesia (e.g., coagulopathy, infection, history of prior spinal surgery, etc.)
Who cannot join
- Contraindications to neuraxial anesthesia
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Neuraxial techniques are the most effective form of labor analgesia in contemporary obstetric anesthesia practice, predominantly through the use of epidural (EPL) and combined spinal-epidural (CSE) techniques. Although drug combinations employed in these methods have advanced, the onset time, block quality, and side effect profiles of both techniques still require further improvement.
The epidural technique is associated with minimal side effects; however, it may occasionally present variable block characteristics such as slow onset, inadequate sacral spread, unilateral or patchy sensory block, motor impairment, and epidural catheter failure.
Read more
The dural puncture epidural (DPE) technique is performed by inserting a spinal needle through the shaft of the epidural needle to create a single dural perforation, after which an epidural catheter is placed into the epidural space without administering any drugs into the cerebrospinal fluid (CSF). All medications for analgesia or anesthesia are delivered into the epidural space via the catheter. The dural puncture is thought to provide a conduit that facilitates the translocation of drugs from the epidural space into the subarachnoid space, which is believed to account for the clinical features observed with the dural puncture epidural technique advantageous in obstetric patients. Additionally, the process of dural puncture with a spinal needle through the epidural needle allows cerebrospinal fluid return to serve as a "confirmatory" definitive endpoint for the position of the epidural needle tip within the epidural space.
The investigators designed this study to determine whether the dural puncture epidural technique, compared with epidural, could improve the onset time and block characteristics of anesthesia in elective cesarean deliveries.
Compared with the epidural technique, the dural puncture epidural approach has been shown to improve the onset of sacral block as well as the spread of anesthesia and analgesia-characteristics that are particularly advantageous in obstetric patients. Additionally, the process of dural puncture with a spinal needle through the epidural needle allows cerebrospinal fluid return to serve as a "confirmatory" definitive endpoint for the position of the epidural needle tip within the epidural space.
The investigators designed this study to determine whether the dural puncture epidural technique, compared with epidural, could improve the onset time and block characteristics of anesthesia in elective cesarean deliveries.
Read the detailed description
This study aims to evaluate the effects of dural puncture epidural (DPE) versus standard epidural anesthesia on the time to surgical anesthesia onset in patients scheduled for elective cesarean section.
- Study Population:
Pregnant women undergoing elective cesarean section
- Compared Techniques:
Dural Puncture Epidural Group → A dural puncture will be performed with a 27G spinal needle before the placement of the epidural catheter.
Standard Epidural Group → An epidural catheter will be placed directly without dural puncture.
- Primary Outcome:
Time from anesthesia administration to onset of surgical anesthesia (defined as time to achieve sensory block at the T5 dermatome level).
- Secondary Outcomes:
Incidence of hypotension
Intraoperative ephedrine requirement
Need for additional doses
Post-dural puncture headache (PDPH)
Time to regression of sensory block
Motor block assessment (Bromage scale)
Study Design:
Prospective: Patients will be identified before anesthesia administration and evaluated going forward.
Randomized: Patients will be randomly assigned to either the dural ponksiyon epidural or standard epidural group.
Controlled: The two groups will be compared to analyze the effects.
Single-Center: The study will be conducted at a single hospital. Inclusion Criteria
- Women scheduled for elective cesarean delivery
- No comorbidities
- Age between 18-40 years
- Body mass index (BMI) < 35 kg/m²
- Term pregnancy ≥ 37 weeks
- No contraindications to neuraxial anesthesia (e.g., coagulopathy, infection, history of prior spinal surgery, etc.)
Parameters to Be Assessed
All parameters will be assessed by the investigator both intraoperatively and postoperatively in the ward. These include:
- Sensory block level (evaluated every minute as a study-specific parameter)
- Blood pressure
- Heart rate
- Oxygen saturation
- Requirement for ephedrine
- Requirement for additional epidural doses
- Incidence of post-dural puncture headache (at 24 and 48 hours)
- Motor block assessment (using the Bromage Scale)
Note: All evaluated parameters are part of standard monitoring, with the exception that sensory block level will be specifically assessed every minute for the purposes of this study.
-
Exclusion Criteria
- Contraindications to neuraxial anesthesia
- Refusal to participate in the study
Withdrawal and Termination Criteria
- Patient's decision to withdraw from the study
- Conversion to general anesthesia
- Administration of intrathecal and/or intravenous drugs
- Being tested
- Dural puncture epidural (DPE) anaesthesia, standart epidural anesthesia
- Keywords
- dural puncture epidural anesthesia, epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural puncture epidural (DPE) anaesthesiaOther
The epidural space will be accessed using an 18G epidural needle, followed by dural puncture with a 27G spinal needle. Without administering any drug into the cerebrospinal fluid (CSF), an epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals.
standart epidural anesthesiaOther
The epidural space will be accessed using an 18G epidural needle. An epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals.
| Study group | Role | What they receive |
|---|---|---|
| dural puncture epidural | Experimental | The epidural space will be accessed using an 18G epidural needle, followed by dural puncture with a 27G spinal needle. Without administering any drug into the cerebrospinal fluid (CSF), an epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. At the completion of the injection (t0), the patient will be placed in the supine position with a 10-degree left tilt. Sensory block level will be assessed every minute using the pinprick test. Bilateral sensory block at the T5 dermatome will be accepted as adequate surgical anaesthesia. Receives: Other: Dural puncture epidural (DPE) anaesthesia |
| standart epidural anesthesia | Active comparator | The epidural space will be accessed using an 18G epidural needle. An epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. At the completion of the injection (t0), the patient will be placed in the supine position with a 10-degree left tilt. Sensory block level will be assessed every minute using the pinprick test. Bilateral sensory block at the T5 dermatome will be accepted as adequate surgical anaesthesia. Receives: Other: standart epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset time of sensory block
The time from the administration of anesthesia to the onset of surgical anesthesia (the time it takes for the sensory block to reach the Thoracic 5 (T5) dermatome).
Measured: 20 minutes
Secondary outcomes (6)
Incidence of hypotension
a 20% reduction from baseline blood pressure
Measured: perioperative
intraoperative ephedrine requirement
total intraoperative ephedrine dose
Measured: perioperative
requirement for supplementery dosing
Failure to achieve sensory block at the Torakal 5 (T5) level within 20 minutes or the occurrence of perioperative pain
Measured: perioperative
Postdural puncture headache (PDPH)
Postoperative headaches will be evaluated at the 24th and 48th hours using the Visual Analog Scale (VAS)
Measured: day 2
Time to the onset of sensory block regression
The duration of sensory block regression from the Thoracic 5 (T5) to the Thoracic 10 (T10) and Lumbar 1 (L1) dermatomal levels
Measured: day 1
Assessment of motor block
The degree of motor block will be assessed using the Bromage score
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Jan 2026
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Regional Anaesthesia in Cesarean OperationsStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Uyar Türkyılmaz, Ankara City Hospital Bilkent
- Investigators
- esra uyar turkyilmaz, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295080
- Sponsor's protocol ID
- 1251153
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharawi N, Williams M, Athar W, Martinello C, Stoner K, Taylor C, Guo N, Sultan P, Mhyre JM. Effect of Dural-Puncture Epidural vs Standard Epidural for Epidural Extension on Onset Time of Surgical Anesthesia in Elective Cesarean Delivery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326710. doi: 10.1001/jamanetworkopen.2023.26710.
PubMed 37526934Rao WY, Xu F, Dai SB, Mei Z, Chen XP, Lv CC, Liu CL, Ngan Kee W, Chen XZ. Comparison of Dural Puncture Epidural, Epidural and Combined Spinal-Epidural Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Drug Des Devel Ther. 2023 Jul 18;17:2077-2085. doi: 10.2147/DDDT.S415684. eCollection 2023.
PubMed 37484190Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
PubMed 28067707
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dural Puncture Epidural and Standard Epidural Anesthesia Techniques in Elective Cesarean Deliveries
- ClinicalTrials.gov ID
- NCT07295080
- Acronym / sponsor ID
- 1251153
- Keywords
- dural puncture epidural anesthesia, epidural anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 19 Dec 2025 (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.
Neuraxial techniques are the most effective form of labor analgesia in contemporary obstetric anesthesia practice, predominantly through the use of epidural (EPL) and combined spinal-epidural (CSE) techniques. Although drug combinations employed in these methods have advanced, the onset time, block quality, and side effect profiles of both techniques still require further improvement.
The epidural technique is associated with minimal side effects; however, it may occasionally present variable block characteristics such as slow onset, inadequate sacral spread, unilateral or patchy sensory block, motor impairment, and epidural catheter failure.
The dural puncture epidural (DPE) technique is performed by inserting a spinal needle through the shaft of the epidural needle to create a single dural perforation, after which an epidural catheter is placed into the epidural space without administering any drugs into the cerebrospinal fluid (CSF). All medications for analgesia or anesthesia are delivered into the epidural space via the catheter. The dural puncture is thought to provide a conduit that facilitates the translocation of drugs from the epidural space into the subarachnoid space, which is believed to account for the clinical features observed with the dural puncture epidural technique advantageous in obstetric patients. Additionally, the process of dural puncture with a spinal needle through the epidural needle allows cerebrospinal fluid return to serve as a "confirmatory" definitive endpoint for the position of the epidural needle tip within the epidural space.
The investigators designed this study to determine whether the dural puncture epidural technique, compared with epidural, could improve the onset time and block characteristics of anesthesia in elective cesarean deliveries.
Compared with the epidural technique, the dural puncture epidural approach has been shown to improve the onset of sacral block as well as the spread of anesthesia and analgesia-characteristics that are particularly advantageous in obstetric patients. Additionally, the process of dural puncture with a spinal needle through the epidural needle allows cerebrospinal fluid return to serve as a "confirmatory" definitive endpoint for the position of the epidural needle tip within the epidural space.
The investigators designed this study to determine whether the dural puncture epidural technique, compared with epidural, could improve the onset time and block characteristics of anesthesia in elective cesarean deliveries.
Detailed description
This study aims to evaluate the effects of dural puncture epidural (DPE) versus standard epidural anesthesia on the time to surgical anesthesia onset in patients scheduled for elective cesarean section.
- Study Population:
Pregnant women undergoing elective cesarean section
- Compared Techniques:
Dural Puncture Epidural Group → A dural puncture will be performed with a 27G spinal needle before the placement of the epidural catheter.
Standard Epidural Group → An epidural catheter will be placed directly without dural puncture.
- Primary Outcome:
Time from anesthesia administration to onset of surgical anesthesia (defined as time to achieve sensory block at the T5 dermatome level).
- Secondary Outcomes:
Incidence of hypotension
Intraoperative ephedrine requirement
Need for additional doses
Post-dural puncture headache (PDPH)
Time to regression of sensory block
Motor block assessment (Bromage scale)
Study Design:
Prospective: Patients will be identified before anesthesia administration and evaluated going forward.
Randomized: Patients will be randomly assigned to either the dural ponksiyon epidural or standard epidural group.
Controlled: The two groups will be compared to analyze the effects.
Single-Center: The study will be conducted at a single hospital. Inclusion Criteria
- Women scheduled for elective cesarean delivery
- No comorbidities
- Age between 18-40 years
- Body mass index (BMI) < 35 kg/m²
- Term pregnancy ≥ 37 weeks
- No contraindications to neuraxial anesthesia (e.g., coagulopathy, infection, history of prior spinal surgery, etc.)
Parameters to Be Assessed
All parameters will be assessed by the investigator both intraoperatively and postoperatively in the ward. These include:
- Sensory block level (evaluated every minute as a study-specific parameter)
- Blood pressure
- Heart rate
- Oxygen saturation
- Requirement for ephedrine
- Requirement for additional epidural doses
- Incidence of post-dural puncture headache (at 24 and 48 hours)
- Motor block assessment (using the Bromage Scale)
Note: All evaluated parameters are part of standard monitoring, with the exception that sensory block level will be specifically assessed every minute for the purposes of this study.
-
Exclusion Criteria
- Contraindications to neuraxial anesthesia
- Refusal to participate in the study
Withdrawal and Termination Criteria
- Patient's decision to withdraw from the study
- Conversion to general anesthesia
- Administration of intrathecal and/or intravenous drugs
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dural puncture epidural | Experimental | Other: Dural puncture epidural (DPE) anaesthesiaThe epidural space will be accessed using an 18G epidural needle, followed by dural puncture with a 27G spinal needle. Without administering any drug into the cerebrospinal fluid (CSF), an epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. At the completion of the injection (t0), the patient will be placed in the supine position with a 10-degree left tilt. Sensory block level will be assessed every minute using the pinprick test. Bilateral sensory block at the T5 dermatome will be accepted as adequate surgical anaesthesia. |
| standart epidural anesthesia | Active comparator | Other: standart epidural anesthesiaThe epidural space will be accessed using an 18G epidural needle. An epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. At the completion of the injection (t0), the patient will be placed in the supine position with a 10-degree left tilt. Sensory block level will be assessed every minute using the pinprick test. Bilateral sensory block at the T5 dermatome will be accepted as adequate surgical anaesthesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women scheduled for elective cesarean delivery
Key exclusion criteria (2 listed)
- Contraindications to neuraxial anesthesia
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) anaesthesiaThe epidural space will be accessed using an 18G epidural needle, followed by dural puncture with a 27G spinal needle. Without administering any drug into the cerebrospinal fluid (CSF), an epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. | Other | dural puncture epidural |
| standart epidural anesthesiaThe epidural space will be accessed using an 18G epidural needle. An epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. | Other | standart epidural anesthesia |
Primary outcome
onset time of sensory block
Time frame: 20 minutes
The time from the administration of anesthesia to the onset of surgical anesthesia (the time it takes for the sensory block to reach the Thoracic 5 (T5) dermatome).
6 secondary outcomes
Incidence of hypotension
Time frame: perioperative
intraoperative ephedrine requirement
Time frame: perioperative
requirement for supplementery dosing
Time frame: perioperative
Postdural puncture headache (PDPH)
Time frame: day 2
Time to the onset of sensory block regression
Time frame: day 1
Assessment of motor block
Time frame: day 1
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 10 Jun 2026.
- Background: PubMed 37526934Sharawi N, Williams M, Athar W, Martinello C, Stoner K, Taylor C, Guo N, Sultan P, Mhyre JM. Effect of Dural-Puncture Epidural vs Standard Epidural for Epidural Extension on Onset Time of Surgical Anesthesia in Elective Cesarean Delivery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326710. doi: 10.1001/jamanetworkopen.2023.26710.
- Background: PubMed 37484190Rao WY, Xu F, Dai SB, Mei Z, Chen XP, Lv CC, Liu CL, Ngan Kee W, Chen XZ. Comparison of Dural Puncture Epidural, Epidural and Combined Spinal-Epidural Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Drug Des Devel Ther. 2023 Jul 18;17:2077-2085. doi: 10.2147/DDDT.S415684. eCollection 2023.
- Background: PubMed 28067707Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
- Individual participant dataSharing planned: No
Related trials for Regional Anaesthesia in Cesarean Operations
RecruitingObservational study
Predictive Value of ONSD and NIRS for PDPH
Post-Dural Puncture Headache, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
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.
esra uyar turkyilmaz principal investigator
Ankara City Hospital Bilkent
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) anaesthesia and standart epidural anesthesia in people with Regional Anaesthesia in Cesarean Operations, run by Ankara City Hospital Bilkent 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 6 inclusion and 2 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 10 Jun 2026. 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?
onset time of sensory block (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07295080, which also lists 3 linked publications.
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 10 Jun 2026.