Effect of Epidural Catheter Retention Depth on Labor Analgesia Performed in DPE Combined With PIEB Model
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
1 other identifier
interventional
102
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2024
CompletedFirst Submitted
Initial submission to the registry
September 17, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedSeptember 19, 2024
July 1, 2024
3 months
September 17, 2024
September 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
First dose in the epidural space to the end of the third stage of labor.
Secondary Outcomes (4)
Related adverse outcomes.
First dose in the epidural space to the end of the third stage of labor.
Anesthesia level and lower limb motor block.
When labor analgesia is satisfactory.
Duration of labor.
From the onset of labor to its end.
Changes in fetal heart rate and uterine contraction pressure.
Before and after labor pain.
Study Arms (3)
3cm group
OTHERWhen 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
OTHERWhen 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
OTHERWhen 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.
Interventions
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）
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）
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）
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General hospital of Ningxia medical university
Yinchuan, Ningxia, 750004, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2024
First Posted
September 19, 2024
Study Start
July 1, 2024
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
September 19, 2024
Record last verified: 2024-07