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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

102

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

July 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Labor Analgesia

Clinical Trials on The indwelling length of epidural catheter is 3 centimeters.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe