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Completed

NCT Number: NCT01935596

Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%

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%.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hervé DUPONT

Amiens, Picardie, 80054, France

About this study

Progress in the practice of anesthesia led to a safety requirement of growing in daily practice. Spinal anesthesia commonly used technique for surgery of the lower limbs, provides a triple neurological lock (sensory, motor and autonomic) of roots of the spinal cord by intrathecal injection of a local anesthetic agent, following the rules of and strict aseptic conditions.

Levobupivacaine and ropivacaine local anesthetic agents are considered less toxic and tend to replace the use of bupivacaine, reference molecule, but the plasma transition is extremely toxic to patients. However, there is currently no study comparing the benefits of levobupivacaine and ropivacaine in isobaric form injected intrathecally for trauma surgery of the lower limbs. We propose to conduct a prospective, randomized double-blind comparison of the use of these two molecules in spinal isobaric form by evaluating the time and duration of action (sensory and motor block), hemodynamic and ventilatory changes (sympathetic block), and the occurrence of any adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • Pregnant or lactating women,
  • Participation in another ongoing clinical trial,
  • Patient on anticoagulant therapy,
  • Patient not affiliated with a social security system.

Treatment and study plan

ropivacaïne

Drug

spinal anesthesia.

lévobupivacaïne

Drug

Primary outcomes

  1. duration of anesthesia on sensitivity

    Time frame: during 6h after induction

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

Secondary outcomes

  1. Duration of anesthesia on motor block

    Time frame: during 6h after induction

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: ROPI-LEVO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 5, 2013
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.