AnalgesiaNCT06156709
Effect of Higher Volume and Lower Dose on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural
A study testing Group I: Lower Volume with Higher Anaesthetic Concentration and Group II: Higher Volume with LowerAnaesthetic Concentration in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed in this study to compare the effect of using local anaesthetics in a higher volume and lower dose on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Group I: Lower Volume with Higher Anaesthetic Concentration and Group II: Higher Volume with LowerAnaesthetic Concentration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2023to 1 Oct 2025
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy nulliparous women
- American Society of Anaesthesiology Score of II
- During active labor
- At weeks 37-42.
- Singlet vertex presentation
- Cervical dilation <5 cm at the request of labor analgesia
- VAS score >40
Who cannot join
- Age <20 or >45,
- Morbid obesity
- Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia)
- History of drug abuse
- Contrindication for neuraxial blocks
- Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries)
Show all 11Show fewer
- Diagnosed fetal abnormalities
- Cases where dura gets punctured unintendedly with the epiduralneedle
- Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture
- Cases where a cesarean section is performed at any stage of labor
- Cases where labor is completed in 1 hour from the start of analgesia procedure.
Trial locations and contacts
1 site in 1 country.
Ayşenur Dostbil contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atatürk University
Erzurum
Aylenur Dostbil, +905333677796, adostbil@hotmail.com
About this study
Official title: The Effect of Using Local Anesthetics in a Higher Volume and Lower Dose On Analgesic Quality of Labor Analgesia With Dural Puncture Epidural Technique: Double-Blind Randomised Controlled Study
It is aimed in this study to compare the effect of using local anaesthetics in a higher volume and lower dose on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.
Read the detailed description
This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.
- Conditions
- Analgesia
- Being tested
- Group I: Lower Volume with Higher Anaesthetic Concentration, Group II: Higher Volume with LowerAnaesthetic Concentration
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I: Lower Volume with Higher Anaesthetic ConcentrationProcedure or surgery
10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered
Group II: Higher Volume with LowerAnaesthetic ConcentrationProcedure or surgery
20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | The patients will be given 10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Level of sensory block will be tested by testing with ice from S2 dermatome cephally.
Analgesia will be maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. In addition, patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered. "Breakthrough pain" that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution. Receives: Procedure: Group I: Lower Volume with Higher Anaesthetic Concentration |
| Group II | Active comparator | The patients will be given 20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Analgesia will be maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. In addition, patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered. "Breakthrough pain" that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution. Receives: Procedure: Group II: Higher Volume with LowerAnaesthetic Concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between total local anaesthetic consumption
The study will involve monitoring the patients starting 2 minutes after the initial epidural dose, every 2 minutes during the first 20 minutes. Monitoring will continue at the 30th minute, and once in every 90 minutes for 5 hours or until labor is completed.
Total bupivacain consumption will be calculated as follows: PIEB + PCEA + boluses by the clinician. Bupivacain consumption per hour will be calculated.
Measured: 5 hours or before if the labor is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start20 Nov 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 54 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
- NCT06156709
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/829
- Status last verified
- Oct 2023
- First submitted
- 26 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. doi: 10.1097/00000539-199605000-00028.
PubMed 8610864Thomas JA, Pan PH, Harris LC, Owen MD, D'Angelo R. Dural puncture with a 27-gauge Whitacre needle as part of a combined spinal-epidural technique does not improve labor epidural catheter function. Anesthesiology. 2005 Nov;103(5):1046-51. doi: 10.1097/00000542-200511000-00019.
PubMed 16249679Wilson SH, Wolf BJ, Bingham K, Scotland QS, Fox JM, Woltz EM, Hebbar L. Labor Analgesia Onset With Dural Puncture Epidural Versus Traditional Epidural Using a 26-Gauge Whitacre Needle and 0.125% Bupivacaine Bolus: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):545-551. doi: 10.1213/ANE.0000000000002129.
PubMed 28622178Kaddoum R, Motlani F, Kaddoum RN, Srirajakalidindi A, Gupta D, Soskin V. Accidental dural puncture, postdural puncture headache, intrathecal catheters, and epidural blood patch: revisiting the old nemesis. J Anesth. 2014 Aug;28(4):628-30. doi: 10.1007/s00540-013-1761-y. Epub 2013 Dec 18.
PubMed 24347033
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Local Anesthetics in a Higher Volume and Lower Dose On Analgesic Quality of Labor Analgesia With Dural Puncture Epidural Technique: Double-Blind Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06156709
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/829
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 5 Dec 2023 (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.
It is aimed in this study to compare the effect of using local anaesthetics in a higher volume and lower dose on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.
Detailed description
This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.
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 |
|---|---|---|
| Group I | Active comparator | Procedure: Group I: Lower Volume with Higher Anaesthetic ConcentrationThe patients will be given 10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Level of sensory block will be tested by testing with ice from S2 dermatome cephally. Analgesia will be maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. In addition, patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered. "Breakthrough pain" that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution. |
| Group II | Active comparator | Procedure: Group II: Higher Volume with LowerAnaesthetic ConcentrationThe patients will be given 20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Analgesia will be maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. In addition, patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered. "Breakthrough pain" that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy nulliparous women
- American Society of Anaesthesiology Score of II
- During active labor
- At weeks 37-42.
- Singlet vertex presentation
Key exclusion criteria (11 listed)
- Age <20 or >45,
- Morbid obesity
- Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia)
- History of drug abuse
- Contrindication for neuraxial blocks
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 |
|---|---|---|
| Group I: Lower Volume with Higher Anaesthetic Concentration10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered | Procedure or surgery | Group I |
| Group II: Higher Volume with LowerAnaesthetic Concentration20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered | Procedure or surgery | Group II |
Primary outcome
Difference between total local anaesthetic consumption
Time frame: 5 hours or before if the labor is completed
The study will involve monitoring the patients starting 2 minutes after the initial epidural dose, every 2 minutes during the first 20 minutes. Monitoring will continue at the 30th minute, and once in every 90 minutes for 5 hours or until labor is completed. Total bupivacain consumption will be calculated as follows: PIEB + PCEA + boluses by the clinician. Bupivacain consumption per hour will be calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 8610864Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. doi: 10.1097/00000539-199605000-00028.
- Background: PubMed 16249679Thomas JA, Pan PH, Harris LC, Owen MD, D'Angelo R. Dural puncture with a 27-gauge Whitacre needle as part of a combined spinal-epidural technique does not improve labor epidural catheter function. Anesthesiology. 2005 Nov;103(5):1046-51. doi: 10.1097/00000542-200511000-00019.
- Background: PubMed 28622178Wilson SH, Wolf BJ, Bingham K, Scotland QS, Fox JM, Woltz EM, Hebbar L. Labor Analgesia Onset With Dural Puncture Epidural Versus Traditional Epidural Using a 26-Gauge Whitacre Needle and 0.125% Bupivacaine Bolus: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):545-551. doi: 10.1213/ANE.0000000000002129.
- Background: PubMed 24347033Kaddoum R, Motlani F, Kaddoum RN, Srirajakalidindi A, Gupta D, Soskin V. Accidental dural puncture, postdural puncture headache, intrathecal catheters, and epidural blood patch: revisiting the old nemesis. J Anesth. 2014 Aug;28(4):628-30. doi: 10.1007/s00540-013-1761-y. Epub 2013 Dec 18.
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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 contact
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 Group I: Lower Volume with Higher Anaesthetic Concentration and Group II: Higher Volume with LowerAnaesthetic Concentration 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 7 inclusion and 11 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 5 Dec 2023. 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?
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?
Difference between total local anaesthetic consumption (time frame: 5 hours or before if the labor is completed). 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 NCT06156709, which also lists 4 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 5 Dec 2023.