Effect of Epidural Catheter Retention Depth on Labor Analgesia Performed in DPE Combined With PIEB Model

September 17, 2024 updated by: General Hospital of Ningxia Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • China
    • Ningxia
      • YinChuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Those aged 18 to 45 years old;
  2. Pregnancy lasts for 37 to 42 weeks;
  3. Single healthy pregnant women with cervical dilation < 3.0 cm who wish to use epidural labor analgesia;
  4. The NRS score of uterine contraction pain is > 3;
  5. ASA grade I-II;
  6. BMI ≤ 40 kg/m².

Exclusion Criteria:

  1. Those with contraindications to intraspinal anesthesia;
  2. Those with a history of allergy to local anesthetics and opioids;
  3. Pregnancy diseases (such as pregnancy-induced hypertension, preeclampsia or gestational diabetes, etc.);
  4. Known fetal abnormalities or situations associated with an increased risk of cesarean section;
  5. Patients who have taken opioids or sedatives within 4 hours before epidural analgesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 3cm group
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.
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, According to different indwelling lengths of epidural catheters as variables, patients are divided into three treatment groups（3cm group 、5cm group and 7cm group）
Other: 5cm group
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.
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, According to different indwelling lengths of epidural catheters as variables, patients are divided into three treatment groups（3cm group 、5cm group and 7cm group）
Other: 7cm group
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.
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, According to different indwelling lengths of epidural catheters as variables, patients are divided into three treatment groups（3cm group 、5cm group and 7cm group）

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
First dose in the epidural space to NRS score being less than 3.
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.
First dose in the epidural space to the end of the third stage of labor.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Related adverse outcomes.
Time Frame: First dose in the epidural space to the end of the third stage of labor.
Occurrence of epidural catheter prolapse, itching, nausea, vomiting, hypotension and unilateral block.
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.
Use the needle prick method to measure the anesthesia level and lower limb motor block after satisfactory labor analgesia.
When labor analgesia is satisfactory.
Duration of labor.
Time Frame: From the onset of labor to its end.
Duration of the first, second, and third stages of labor.
From the onset of labor to its end.
Changes in fetal heart rate and uterine contraction pressure.
Time Frame: Before and after labor pain.
Observe the changes in fetal heart rate and uterine contraction pressure before and after labor pain.
Before and after labor pain.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
General Hospital of Ningxia Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Peng Liu-2024-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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