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Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant

NCT ID: NCT03433976

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-07

Study Completion Date

2020-08-30

Brief Summary

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The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. The purpose of this study is to show a reduction in motor block time with hyperbaric Prilocaine by at least 30 minutes, which would allow mothers and their children to return to the maternity ward earlier and thus improve the circulation of patients within the maternity's PACU.

Detailed Description

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Prospective study, randomized into two parallel groups (Hyperbaric Prilocaïne versus hyperbaric Bupivacaine), double-blind, monocentric (Clinique Saint Roch in Montpellier).

The number of subjects required is 50 patients, 25 per group.

Conditions

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Cesarean

Keywords

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Caesarean section spinal anesthesia Prilocaïne motor block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hyperbaric Bupivacaine

spinal anesthesia for planned cesarean sections control group

Group Type OTHER

spinal anesthesia

Intervention Type DRUG

spinal anesthesia for planned cesarean sections

Hyperbaric Prilocaïne

spinal anesthesia for planned cesarean sections

Group Type ACTIVE_COMPARATOR

spinal anesthesia

Intervention Type DRUG

spinal anesthesia for planned cesarean sections

Interventions

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spinal anesthesia

spinal anesthesia for planned cesarean sections

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal pregnancy
* Scheduled caesarean section
* Non-multiple pregnancy
* Age of patient: 18 years and over
* Height of patient: between 155 and 175 cm
* Affiliated patients or beneficiaries of a Social Security System
* Signature of the patient's consent

Exclusion Criteria

* Patient \<18 years
* Pathological pregnancy
* Multiple pregnancy
* Emergency caesarean
* Patients who cannot give informed consent (not French speaking)
* Refusal of the patient
* Contraindications to spinal anesthesia
* Contraindications to Prilocaine
* Contraindications to Bupivacaine
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Saint Roch

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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christophe DADURE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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christophe DADURE, MD, PhD

Role: CONTACT

Phone: 467338256

Email: [email protected]

Facility Contacts

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Christophe DADURE, MD, phD

Role: primary

References

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Chapron K, Sleth JC, Capdevila X, Bringuier S, Dadure C. Hyperbaric prilocaine vs. hyperbaric bupivacaine for spinal anaesthesia in women undergoing elective caesarean section: a comparative randomised double-blind study. Anaesthesia. 2021 Jun;76(6):777-784. doi: 10.1111/anae.15342. Epub 2021 Jan 11.

Reference Type DERIVED
PMID: 33428221 (View on PubMed)

Other Identifiers

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UF9859

Identifier Type: -

Identifier Source: org_study_id