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

Overview

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

Full Title of Study: “Spinale Unilaterale o Blocco Nervoso Periferico Per le Artroscopie di Ginocchio in Day Surgery. Confronto Prospettico Randomizzato”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: May 2015

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.

Interventions

  • Drug: prilocaine
  • Drug: mepivacaine
  • Procedure: Sciatic-femoral Nerve Block
    • ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve
  • Procedure: Spinal anesthesia
    • intrathecal injection of 40 mg hyperbaric prilocaine
  • Device: Sonoplex, Pajunk

Arms, Groups and Cohorts

  • 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).
  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Time to home discharge
    • Time Frame: 12 hours

Participating in This Clinical Trial

Inclusion Criteria

  • outpatients knee arthroscopy Exclusion Criteria:

  • diabetes – allergy to local anesthetic – patient refusal – chronic opiods assumption

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ASST Gaetano Pini-CTO
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gianluca Cappelleri, Medical Doctor – ASST Gaetano Pini-CTO

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