NCT03433976

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

December 11, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

December 21, 2017

Last Update Submit

December 10, 2018

Conditions

Cesarean

Keywords

Caesarean sectionspinal anesthesiaPrilocaïnemotor block

Outcome Measures

Primary Outcomes (1)

  • duration of motor block

    To compare the duration of motor block after spinal anesthesia with hyperbaric Prilocaïne versus hyperbaric Bupivacaine This evaluation is done every 15 min from the entrance to the recovery room (PACU); the motor block stops being evaluated when the modified bromination score reaches 4

    up to 6 hours

Secondary Outcomes (13)

  • The upper sensory level

    15 minutes after the LA injection

  • Hypotensive episodes

    1 day

  • The time between injection and incision

    1 day

  • The duration of the intervention

    1 day

  • The time to return to the standard maternity ward

    1 day

  • +8 more secondary outcomes

Study Arms (2)

Hyperbaric Bupivacaine

OTHER

spinal anesthesia for planned cesarean sections control group

Drug: spinal anesthesia

Hyperbaric Prilocaïne

ACTIVE COMPARATOR

spinal anesthesia for planned cesarean sections

Drug: spinal anesthesia

Interventions

spinal anesthesiaDRUG

spinal anesthesia for planned cesarean sections

Hyperbaric BupivacaineHyperbaric Prilocaïne

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33428221DERIVED

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • christophe DADURE

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

christophe DADURE, MD, PhD

CONTACT

467338256c-dadure@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

February 15, 2018

Study Start

May 7, 2018

Primary Completion

May 7, 2020

Study Completion

August 30, 2020

Last Updated

December 11, 2018

Record last verified: 2018-03

Locations

FR(1)