Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602440
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Effect of Epidural Catheter Retention Depth on Labor Analgesia Performed in DPE Combined With PIEB Model
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Observations on the Effect of Different Depths of Epidural Catheter Retention on the DPE Technique Combined With the PIEB Mode of Labor Analgesiaa Single-center Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Zhendongs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None