Labor AnalgesiaNCT06602440
Effect of Epidural Catheter Retention Depth on Labor Analgesia Performed in DPE Combined With PIEB Model
A study testing The indwelling length of epidural catheter is 3 centimeters., The indwelling length of epidural catheter is 5 centimeters. and The indwelling length of epidural catheter is 7 centimeters. in people with Labor Analgesia, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The purpose of this study is to observe the appropriate indwelling depth of epidural catheter when labor analgesia is performed in the mode of DPE combined with PIEB, and then shorten the onset time of labor analgesia and reduce the occurrence of catheter-related adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Analgesia
- What is being tested?
- The indwelling length of epidural catheter is 3 centimeters., The indwelling length of epidural catheter is 5 centimeters. and The indwelling length of epidural catheter is 7 centimeters.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Oct 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those aged 18 to 45 years old;
- Pregnancy lasts for 37 to 42 weeks;
- Single healthy pregnant women with cervical dilation < 3.0 cm who wish to use epidural labor analgesia;
- The NRS score of uterine contraction pain is > 3;
- ASA grade I-II;
- BMI ≤ 40 kg/m².
Who cannot join
- Those with contraindications to intraspinal anesthesia;
- Those with a history of allergy to local anesthetics and opioids;
- Pregnancy diseases (such as pregnancy-induced hypertension, preeclampsia or gestational diabetes, etc.);
- Known fetal abnormalities or situations associated with an increased risk of cesarean section;
- Patients who have taken opioids or sedatives within 4 hours before epidural analgesia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General hospital of Ningxia medical university
Yinchuan, Ningxia, 750004
xinli Ni, 86-0951-6743252, xinlini6@nyfy.com.cn
About this study
Official title: Observations on the Effect of Different Depths of Epidural Catheter Retention on the DPE Technique Combined With the PIEB Mode of Labor Analgesia：a Single-center, Prospective, Randomized Controlled Study
The purpose of this study is to observe the appropriate indwelling depth of epidural catheter when labor analgesia is performed in the mode of DPE combined with PIEB, and then shorten the onset time of labor analgesia and reduce the occurrence of catheter-related adverse outcomes.
Read the detailed description
In clinical practice, neuraxial analgesia is the most effective method for labor analgesia, including combined spinal-epidural (CSE) analgesia, dural puncture epidural (DPE) analgesia, and conventional epidural (EP) analgesia. Among them, DPE technology is an improvement of CSE technology. It means using a spinal needle to puncture the dura mater but not injecting drugs into the intrathecal space. Then, the epidural catheter is inserted into the epidural space. The punctured dura mater creates a new pathway for drug displacement from the epidural space to the subarachnoid space. In theory, compared with EP, DPE technology makes drugs enter the subarachnoid space more easily and can achieve a faster onset time of analgesia. At the same time, compared with CSE, the amount of drugs entering the subarachnoid space is not excessive, which can reduce the occurrence of adverse reactions such as itching and hypotension. At present, although there is controversy over the clinical advantages of DPE, its effectiveness has been confirmed in the article published by Gunaydin B et al. in 2019. In a series of RCT trials conducted by Professor Xu Zhendong's team in China, it is believed that the effect of DPE is related to the drug injection mode in the epidural space, the thickness of the puncture needle, and the distance between the drug outlet end and the puncture hole. At the same time, DPE technology combined with programmed intermittent epidural bolus (PIEB) mode seems to be a better choice in labor analgesia. Because the single drug bolus dose generated under the PIEB mode creates greater pressure in the epidural space, which is more conducive to drugs entering the subarachnoid space through the puncture hole. Based on the above research, when performing labor analgesia in the DPE combined with PIEB mode, we believe that the closer the opening of the epidural catheter is to the puncture hole, the easier it is for drugs to generate local pressure around the puncture hole and thus enter the subarachnoid space. This is related to the indwelling depth of the epidural catheter. The shorter the indwelling depth, the more drugs may enter the puncture hole, but it will also increase the probability of catheter detachment. The longer the indwelling depth, the farther the local pressure generated is from the puncture hole, and the advantage of the PIEB mode may be masked. At the same time, an excessively long indwelling depth will increase the incidence of unilateral block.
- Conditions
- Labor Analgesia
- Being tested
- The indwelling length of epidural catheter is 3 centimeters., The indwelling length of epidural catheter is 5 centimeters., The indwelling length of epidural catheter is 7 centimeters.
- Keywords
- Uterine contraction pain, Dural puncture epidural technique（DPE）, Programmed intermittent epidural bolus（PIEB）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The indwelling length of epidural catheter is 3 centimeters.Procedure or surgery
When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, According to different indwelling lengths of epidural catheters as variables, patients are divided into three treatment groups（3cm group 、5cm group and 7cm group）
The indwelling length of epidural catheter is 5 centimeters.Procedure or surgery
When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, According to different indwelling lengths of epidural catheters as variables, patients are divided into three treatment groups（3cm group 、5cm group and 7cm group）
The indwelling length of epidural catheter is 7 centimeters.Procedure or surgery
When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, According to different indwelling lengths of epidural catheters as variables, patients are divided into three treatment groups（3cm group 、5cm group and 7cm group）
| Study group | Role | What they receive |
|---|---|---|
| 3cm group | Other | When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, the indwelling depth of the epidural catheter is 3 centimeters. Receives: Procedure: The indwelling length of epidural catheter is 3 centimeters. |
| 5cm group | Other | When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, the indwelling depth of the epidural catheter is 5 centimeters. Receives: Procedure: The indwelling length of epidural catheter is 5 centimeters. |
| 7cm group | Other | When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, the indwelling depth of the epidural catheter is 7 centimeters. Receives: Procedure: The indwelling length of epidural catheter is 7 centimeters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of satisfactory analgesia.
The time when the NRS score is less than 3 after the first administration during labor analgesia with DPE combined with PIEB mode.
Measured: First dose in the epidural space to NRS score being less than 3.
Consumption of ropivacaine per unit time.
The consumption of ropivacaine per unit time during the entire labor analgesia process.
Measured: First dose in the epidural space to the end of the third stage of labor.
Secondary outcomes (4)
Related adverse outcomes.
Occurrence of epidural catheter prolapse, itching, nausea, vomiting, hypotension and unilateral block.
Measured: First dose in the epidural space to the end of the third stage of labor.
Anesthesia level and lower limb motor block.
Use the needle prick method to measure the anesthesia level and lower limb motor block after satisfactory labor analgesia.
Measured: When labor analgesia is satisfactory.
Duration of labor.
Duration of the first, second, and third stages of labor.
Measured: From the onset of labor to its end.
Changes in fetal heart rate and uterine contraction pressure.
Observe the changes in fetal heart rate and uterine contraction pressure before and after labor pain.
Measured: Before and after labor pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602440
- Sponsor's protocol ID
- Peng Liu-2024-2
- Status last verified
- Jul 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu P, Chen Y, Ma P, Qin R, Shi Y, Ni X. Appropriate length of epidural catheter in epidural space for labour analgesia with dural puncture epidural combined with programmed intermittent epidural bolus. BMC Anesthesiol. 2026 Jan 20;26(1):123. doi: 10.1186/s12871-026-03637-x.
PubMed 41559579
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observations on the Effect of Different Depths of Epidural Catheter Retention on the DPE Technique Combined With the PIEB Mode of Labor Analgesia：a Single-center, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06602440
- Acronym / sponsor ID
- Peng Liu-2024-2
- Conditions
- Labor Analgesia
- Keywords
- Uterine contraction pain, Dural puncture epidural technique（DPE）, Programmed intermittent epidural bolus（PIEB）
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 19 Sep 2024 (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 purpose of this study is to observe the appropriate indwelling depth of epidural catheter when labor analgesia is performed in the mode of DPE combined with PIEB, and then shorten the onset time of labor analgesia and reduce the occurrence of catheter-related adverse outcomes.
Detailed description
In clinical practice, neuraxial analgesia is the most effective method for labor analgesia, including combined spinal-epidural (CSE) analgesia, dural puncture epidural (DPE) analgesia, and conventional epidural (EP) analgesia. Among them, DPE technology is an improvement of CSE technology. It means using a spinal needle to puncture the dura mater but not injecting drugs into the intrathecal space. Then, the epidural catheter is inserted into the epidural space. The punctured dura mater creates a new pathway for drug displacement from the epidural space to the subarachnoid space. In theory, compared with EP, DPE technology makes drugs enter the subarachnoid space more easily and can achieve a faster onset time of analgesia. At the same time, compared with CSE, the amount of drugs entering the subarachnoid space is not excessive, which can reduce the occurrence of adverse reactions such as itching and hypotension. At present, although there is controversy over the clinical advantages of DPE, its effectiveness has been confirmed in the article published by Gunaydin B et al. in 2019. In a series of RCT trials conducted by Professor Xu Zhendong's team in China, it is believed that the effect of DPE is related to the drug injection mode in the epidural space, the thickness of the puncture needle, and the distance between the drug outlet end and the puncture hole. At the same time, DPE technology combined with programmed intermittent epidural bolus (PIEB) mode seems to be a better choice in labor analgesia. Because the single drug bolus dose generated under the PIEB mode creates greater pressure in the epidural space, which is more conducive to drugs entering the subarachnoid space through the puncture hole. Based on the above research, when performing labor analgesia in the DPE combined with PIEB mode, we believe that the closer the opening of the epidural catheter is to the puncture hole, the easier it is for drugs to generate local pressure around the puncture hole and thus enter the subarachnoid space. This is related to the indwelling depth of the epidural catheter. The shorter the indwelling depth, the more drugs may enter the puncture hole, but it will also increase the probability of catheter detachment. The longer the indwelling depth, the farther the local pressure generated is from the puncture hole, and the advantage of the PIEB mode may be masked. At the same time, an excessively long indwelling depth will increase the incidence of unilateral block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3cm group | Other | Procedure: The indwelling length of epidural catheter is 3 centimeters.When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, the indwelling depth of the epidural catheter is 3 centimeters. |
| 5cm group | Other | Procedure: The indwelling length of epidural catheter is 5 centimeters.When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, the indwelling depth of the epidural catheter is 5 centimeters. |
| 7cm group | Other | Procedure: The indwelling length of epidural catheter is 7 centimeters.When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, the indwelling depth of the epidural catheter is 7 centimeters. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Those aged 18 to 45 years old;
- Pregnancy lasts for 37 to 42 weeks;
- Single healthy pregnant women with cervical dilation < 3.0 cm who wish to use epidural labor analgesia;
- The NRS score of uterine contraction pain is > 3;
- ASA grade I-II;
Key exclusion criteria (5 listed)
- Those with contraindications to intraspinal anesthesia;
- Those with a history of allergy to local anesthetics and opioids;
- Pregnancy diseases (such as pregnancy-induced hypertension, preeclampsia or gestational diabetes, etc.);
- Known fetal abnormalities or situations associated with an increased risk of cesarean section;
- Patients who have taken opioids or sedatives within 4 hours before epidural analgesia.
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 |
|---|---|---|
| The indwelling length of epidural catheter is 3 centimeters.When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, According to different indwelling lengths of epidural catheters as variables, patients are divided into three treatment groups（3cm group 、5cm group and 7cm group） | Procedure or surgery | 3cm group |
| The indwelling length of epidural catheter is 5 centimeters.When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, According to different indwelling lengths of epidural catheters as variables, patients are divided into three treatment groups（3cm group 、5cm group and 7cm group） | Procedure or surgery | 5cm group |
| The indwelling length of epidural catheter is 7 centimeters.When performing Dural Puncture Epidural technique with Programmed Intermittent Epidural Bolus（PIEB） mode for labor analgesia, According to different indwelling lengths of epidural catheters as variables, patients are divided into three treatment groups（3cm group 、5cm group and 7cm group） | Procedure or surgery | 7cm group |
Primary outcome
Time of satisfactory analgesia.
Time frame: First dose in the epidural space to NRS score being less than 3.
The time when the NRS score is less than 3 after the first administration during labor analgesia with DPE combined with PIEB mode.
Consumption of ropivacaine per unit time.
Time frame: First dose in the epidural space to the end of the third stage of labor.
The consumption of ropivacaine per unit time during the entire labor analgesia process.
4 secondary outcomes
Related adverse outcomes.
Time frame: First dose in the epidural space to the end of the third stage of labor.
Anesthesia level and lower limb motor block.
Time frame: When labor analgesia is satisfactory.
Duration of labor.
Time frame: From the onset of labor to its end.
Changes in fetal heart rate and uterine contraction pressure.
Time frame: Before and after labor pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41559579Liu P, Chen Y, Ma P, Qin R, Shi Y, Ni X. Appropriate length of epidural catheter in epidural space for labour analgesia with dural puncture epidural combined with programmed intermittent epidural bolus. BMC Anesthesiol. 2026 Jan 20;26(1):123. doi: 10.1186/s12871-026-03637-x.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The indwelling length of epidural catheter is 3 centimeters., The indwelling length of epidural catheter is 5 centimeters. and The indwelling length of epidural catheter is 7 centimeters. in people with Labor Analgesia, run by General Hospital of Ningxia Medical University at 1 site in China.
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 5 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 19 Sep 2024. 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 China. 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 xinli Ni, MD (13909586966, xinlini6@nyfy.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of satisfactory analgesia. (time frame: First dose in the epidural space to NRS score being less than 3.). The study lists 2 primary outcomes in all. 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 NCT06602440, which also lists 1 linked publication.
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 19 Sep 2024.