NCT01935596

Brief Summary

This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

August 23, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

August 23, 2012

Last Update Submit

November 17, 2025

Conditions

Patients Undergoing Lower Limb Surgery

Keywords

AnesthesiaRandomized studyLower limbs surgery

Outcome Measures

Primary Outcomes (1)

  • duration of anesthesia on sensitivity

    Thermo-algesic exploration of sensitivity through the application of an ice cube

    during 6h after induction

Secondary Outcomes (1)

  • Duration of anesthesia on motor block

    during 6h after induction

Study Arms (2)

ropivacaïne 0,5%,

ACTIVE COMPARATOR

intrathecal administration of 15mg of ropivacaine 0.5%.

Drug: ropivacaïne

lévobupivacaïne 0,5%

ACTIVE COMPARATOR

intrathecal administration of 15mg of levobupivacaine 0.5%

Drug: lévobupivacaïne

Interventions

ropivacaïneDRUG

spinal anesthesia.

ropivacaïne 0,5%,
lévobupivacaïneDRUG
lévobupivacaïne 0,5%

Eligibility Criteria

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

You may qualify if:

  • patient admitted to the emergency for lower limb trauma,
  • age over 18 years and below 65 years
  • lower limb trauma surgery can be performed under spinal anesthesia.

You may not qualify if:

  • Refusal of patients to participate in the study,
  • Patient with cons-indication to spinal anesthesia:
  • Local anesthetic allergy agents (1/13000)
  • bleeding disorders, including pharmacological origin
  • infection at the puncture site,
  • refusal of spinal anesthesia by the patient,
  • Patient trust,
  • Patients whose coagulation is abnormal.
  • Patients with cognitive impairment or incapacitated adult,
  • Multiple trauma,
  • Porphyria,
  • Central preexisting neuropathy,
  • A history of spinal surgery,
  • Epilepsy uncontrolled by treatment,
  • Hypovolemia,
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hervé DUPONT

Amiens, Picardie, 80054, France

Location

Related Publications (1)

  • https://www.em-consulte.com/article/998410/comparaison-de-l-efficacite-de-la-levobupivacaine-

    RESULT

Study Officials

  • Hervé DUPONT, Professor

    CHU Amiens France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 5, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

FR(1)