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

May 7, 2015 updated by: Gianluca Cappelleri, ASST Gaetano Pini-CTO

Spinale Unilaterale o Blocco Nervoso Periferico Per le Artroscopie di Ginocchio in Day Surgery. Confronto Prospettico Randomizzato

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Milan, Milano, Italy, 20122
        • Istituto Ortopedico G. Pini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatients knee arthroscopy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to home discharge
Time Frame: 12 hours
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Gaetano Pini-CTO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (ESTIMATE)

March 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOGPGC07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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