Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block

NCT00567450 | Completed Phase 4

• 3 other identifiers: 2007-002254-31EudraCT: 2007-002254-31AFFSAPS: A70388-33
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest. This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.

Conditions

Subgluteal Sciatic Block

Keywords

sciatic block; ropivacaine; mepivacaine; locoregional anesthesia

Outcome Measures

Primary Outcomes (1)

• Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve

  4h

Secondary Outcomes (1)

• intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, and its side effects.

  48h

Study Arms (2)

B

ACTIVE COMPARATOR

30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%

Drug: ropivacaine plus mepivacaine

A

EXPERIMENTAL

30 ml of ropivacaine 0.75%

Drug: ropivacaine

Interventions

ropivacaine DRUG

30ml of a mixture of ropivacaïne 0.75%

A

ropivacaine plus mepivacaine DRUG

30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• surgery of the foot under sciatic block

You may not qualify if:

• no indication of locoregional anesthesia
• polyneuropathy or any neurological disease
• know hypersensitivity to local anesthetics
• porphyria
• atrio-ventricular block
• not controlled epilepsia
• hypovolemia
• pregnancy
• anticoagulant treatment

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU d'Amiens, Pole Anesthesie Réanimation, Place Victor Pauchet

Amiens, 80054, France

Location

MeSH Terms

Interventions

Ropivacaine; Mepivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Campana Philippe, MD

  Anesthesiology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

FR (1)