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Sacral Spread of Sensory Block After Dural Puncture Epidural Technique Compared With Epidural for Labour Analgesia

NCT05217134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-10-12

No results posted yet for this study

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.

Conditions

  • Labor Pain
  • Analgesia

Interventions

PROCEDURE

DPEA

Dural puncture with 27 G Whitacre needle

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-06-30
Completion
2022-09-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217134 on ClinicalTrials.gov