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Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block

Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00567450
Enrollment
30
Registered
2007-12-05
Start date
2007-09-30
Completion date
2008-09-30
Last updated
2009-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subgluteal Sciatic Block

Keywords

sciatic block, ropivacaine, mepivacaine, locoregional anesthesia

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.

Interventions

DRUGropivacaine

30ml of a mixture of ropivacaïne 0.75%

DRUGropivacaine plus mepivacaine

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve4h

Secondary

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026