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Study PIEB vs PIEB: the Dose is it Variable According to the Patients (DOPABIEB)

R

Rennes University Hospital

Status

Completed

Conditions

Anesthesia, Epidural
Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT03690271
35RC17_3083_DOPABIEB

Details and patient eligibility

About

the main objective of this study is to compare the effectiveness of three groups of epidurals with three different programmed intermittent epidural bolus (PIEB)settings.

Full description

In a PIEB, the concentration of local anesthetics administered is standardized in the services according to the recommendations. What is left to the judgement of the clinician, taking care of the patient during the work, is the administered dose. This often varies according to clinician deductions that take notice of height, weight, previous pregnancies In the CHU of Rennes, three dosages are used in common practice. The objective by comparing these three dosages is to show if there is a significant difference between the groups.

Enrollment

170 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient over 18 years old.
  • Pregnant patient, during labor, live fetus, for whom a PIEB is desired / programmed.
  • Patient not objecting to their participation in the study.

Exclusion criteria

  • Hemostasis disorder contraindicated the epidural
  • Eclampsia
  • Caesarean section straightaway
  • Patient under legal protection (guardianship, curatorship, safeguard of justice).

Trial design

170 participants in 3 patient groups

Groupe 5-5
Description:
Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way : 5 ml * dose to be administered every hour by the patient : 5 ml
groupe 6-6
Description:
Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way : 6 ml * dose to be administered every hour by the patient : 6 ml
groupe 7-7
Description:
Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way :7 ml * dose to be administered every hour by the patient :7 ml

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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