General hospital of Ningxia medical university
Yinchuan, Ningxia, 750004, China
Location status: Recruiting
NCT Number: NCT06602440
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Yinchuan, Ningxia, 750004, China
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
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.
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.
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.
Time frame: From the onset of labor to its end.
Duration of the first, second, and third stages of labor.
Time frame: Before and after labor pain.
Observe the changes in fetal heart rate and uterine contraction pressure before and after labor pain.
Contact information is provided by the study sponsor or research team.
General Hospital of Ningxia Medical University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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