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Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy

Sponsor
ASST Gaetano Pini-CTO (Other)
Overall Status
Completed
CT.gov ID
NCT02384915
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
3.9
Duration (Months)
25.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to compare the time of home discharge in day-case patients receiving either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Two groups: the first receive a spinal anesthesia injecting 2% hyperbaric prilocaine 40 mg with the patients in lateral decubitus and the surgical limb declive, the second a combined ultrasound-guided sciatic-femoral nerve block injecting 25 ml of 2% mepivacaine solution.

Onset time, performance time, duration of the block, time of voiding, as well as the time of home discharge will be evaluated.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Spinale Unilaterale o Blocco Nervoso Periferico Per le Artroscopie di Ginocchio in Day Surgery. Confronto Prospettico Randomizzato
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Spinal anesthesia

Intrathecal injection of 2 ml (40 mg) of 2% hyperbaric prilocaine at L3-L4 interspaces through a 100mm Sprotte 25 G spinal needle (Pencan, b-brawn, Germay) in lateral decubitus position, (with limb to operate declive).

Drug: prilocaine
Other Names:
  • prilotekal

    • Procedure: Spinal anesthesia
    intrathecal injection of 40 mg hyperbaric prilocaine
    Active Comparator: peripheral nerve block

    Ultrasound-guided sciatic-femoral nerve block injecting 25 ml of a 2% mepivacaine solution,15 ml on femoral nerve and 10 ml on sciatic nerve through a 80 mm 22g eco-reflex needle (Sonoplex, Pajunk, Germany)

    Drug: mepivacaine
    Other Names:
  • carbocaine

    • Procedure: Sciatic-femoral Nerve Block
    ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve

    Device: Sonoplex, Pajunk

    Outcome Measures

    Primary Outcome Measures

    1. Time to home discharge [12 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • outpatients knee arthroscopy
    Exclusion Criteria:

    • diabetes

    • allergy to local anesthetic

    • patient refusal

    • chronic opiods assumption

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istituto Ortopedico G. Pini Milan Milano Italy 20122

    Sponsors and Collaborators

    • ASST Gaetano Pini-CTO

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gianluca Cappelleri, Medical Doctor, ASST Gaetano Pini-CTO
    ClinicalTrials.gov Identifier:
    NCT02384915
    Other Study ID Numbers:
    • IOGPGC07
    First Posted:
    Mar 10, 2015
    Last Update Posted:
    May 8, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Arthritis
    Prilocaine
    Mepivacaine

    Study Results

    No Results Posted as of May 8, 2015