Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale

NCT00956709 | Terminated Phase 4 Results

• 1 other identifier: BRD/08/05-D
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major surgery of the foot. The literature does not highlight a significant difference in terms of onset of action between these two molecules to block the sciatic nerve \[4\]. Our hypothesis is that this lack of difference is due to the use of a neurostimulator for locating the injection site (indiscriminate nature of the anatomical approach to the sciatic nerve). Indeed, the sensitivity of neurostimulation is low compared with ultrasound \[58\] and ultrasound, for accurate visualization of the deposit of the local anesthetic around the nerve to improve the quality of the block and reduce the onset of action of local anesthetic \[46, 47\]. The investigators propose to make a comparative trial between levobupivacaïne 0.5% ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block. The use of ultrasound will reduce the variability of results because the changes would be linked exclusively to the local anesthetic. The investigators test the hypothesis that levobupivacaïne gives better results in terms of onset of action than ropivacaine.

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (1)

• Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot

  72 hours

Secondary Outcomes (3)

• Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.

  72 hours

• Duration of Motor Sciatic Block (h)

  72 hours

• Duration of Sensory Sciatic Block (h)

  72 hours

Study Arms (2)

Levobupivacaïne 0,5 %

ACTIVE COMPARATOR

Drug: levobupivacaïne 0,5 %

Ropivacaïne 0,5%

ACTIVE COMPARATOR

Drug: ropivacaïne 0,5 %

Interventions

levobupivacaïne 0,5 % DRUG

20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %

Levobupivacaïne 0,5 %

ropivacaïne 0,5 % DRUG

20mL de ropivacaïne 0,5 %

Ropivacaïne 0,5%

Eligibility Criteria

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

You may qualify if:

• Patients with unilateral major surgery of the foot: hallux valgus (not ambulatory), claw toes, fusion-Astragalo calcaneum, complex syntheses of tarsus-aged over 18 years .
• Male and female
• ASA 1 or 2
• Insured Social
• Informed Consent

You may not qualify if:

• Diabetes
• Intoxication-alcoholic chronic
• Allergy to local anesthetics
• Hemostasis disorders
• Hepatic failure
• Chronic pain syndrome

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Results Point of Contact

• Title: Dr Pham Dang
• Organization: CHU de Nantes

charles.phamdang@chu-nantes.fr

33 2 53 48 24 15

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: December 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 5, 2016
• Results First Posted: August 1, 2014

Record last verified: 2016-10

Locations

FR (1)