CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
DPEAprocedure
Likely dose
Not stated in record
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Search/NCT05217134
NCT05217134N/ACompleted

Sacral Anesthetic Block During Labor Analgesia With a With a 27-G Whitacre Spinal Needle - Dural Puncture Epidural Technique vs Standard Epidural Technique: a Randomized Controlled Study.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·interventional·Posted Feb 1, 2022·Updated Oct 12, 2022

In Brief

A clinical study evaluating DPEA for Labor Pain and Analgesia. Completed, enrolled 108 participants across 2 sites.

Detailed Summary

Neuraxial labor analgesia is a very widely used technique for labor pain relief with a high efficacy and safety. EA (Epidural analgesia) can guarantee a proper control of pain in 95-100% of cases in the first stage of labor, but in the second stage his efficacy is not always adequate. DPEA (Dural Puncture Epidural Analgesia) is a variation of the conventional EA and technically a modified version of the CSE (Combined Spinal Epidural) analgesia. When compared with the traditional EA, DPEA showed satisfying, effective and fast control of labor pain, no motor block and less need for anesthetic boluses given through the epidural catheter when the maintenance of analgesia was guaranteed with manual top-ups, as well as less request for extra boluses of anesthetic when PIEB (Programmed Intermittent Epidural Boluses) was chosen for the maintenance of analgesia. Studies proved that DPEA is a safe technique and no statistically significant incidence of side effects for mothers and fetuses was observed. The hypothesis of this study is that a DPEA performed with a 27 G Whitacre spinal needle can especially improve the spread in the sacral region. The primary outcome of this study is to evaluate whether the DPEA performed with a 27-G Whitacre spinal needle is more effective in ensuring satisfying analgesia as a result of a better sacral analgesic spread, compared to the traditional EA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 1, 2022
Enrollment StartMar 1, 2022
Primary CompletionJun 30, 2022
Study CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.4 years ago

Interventions

DPEAprocedure

Dural puncture with 27 G Whitacre needle