NCT01935596

CompletedPhase 4

Comparative Study of the Effects of Two Local Anesthetics Ad...

Centre Hospitalier Universitaire, Amiens Source

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Other study identifiers

Sponsor study identifier

PI09-PR-DUPONT

Study Type

interventional

Actual enrollment (reported)

50

Locations

1 country

Sites

1

Timeline

Study Start

May 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2014

Actual (reported)

Study Completion

April 2014

Actual (reported)

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%.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 50 participants
Study completion date: April 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 23, 2012
Actual (reported)
Study Start
May 2013
Date type not reported
This date has not been verified as actual or estimated.
First Posted
September 5, 2013
Actual (reported)
Primary Completion
April 2014
Actual (reported)
Study Completion
April 2014
Actual (reported)

Last Updated: November 19, 2025
Status Verified: November 2025
Last Update Submitted: 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%

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Centre Hospitalier Universitaire, Amiens
Otherlead

Study Sites (1)

Hervé DUPONT

Amiens, Picardie, 80054, France

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

Enrollment

50 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

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.

Primary Completion

April 2014

Actual (reported)

Study Completion

April 2014

Actual (reported)

Last Updated

November 19, 2025

Record last verified: 2025-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01935596
Data provider: ClinicalTrials.gov
Source updated: 2025-11-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:36 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

ropivacaïne 0,5%,

lévobupivacaïne 0,5%

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations