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

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ClinicalTrials.gov Identifier: NCT02384915
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
Gianluca Cappelleri, ASST Gaetano Pini-CTO

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
Knee Arthritis Drug: prilocaine Drug: mepivacaine Procedure: Sciatic-femoral Nerve Block Procedure: Spinal anesthesia Device: Sonoplex, Pajunk 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: carbocaine

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

Device: Sonoplex, Pajunk



Primary Outcome Measures :
  1. Time to home discharge [ Time Frame: 12 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • outpatients knee arthroscopy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384915


Locations
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Italy
Istituto Ortopedico G. Pini
Milan, Milano, Italy, 20122
Sponsors and Collaborators
ASST Gaetano Pini-CTO
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Responsible Party: Gianluca Cappelleri, Medical Doctor, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier: NCT02384915    
Other Study ID Numbers: IOGPGC07
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases
Prilocaine
Mepivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents