Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy
Primary Purpose
Knee Arthritis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
prilocaine
mepivacaine
Sciatic-femoral Nerve Block
Spinal anesthesia
Sonoplex, Pajunk
Sponsored by
About this trial
This is an interventional treatment trial for Knee Arthritis
Eligibility Criteria
Inclusion Criteria:
- outpatients knee arthroscopy
Exclusion Criteria:
- diabetes
- allergy to local anesthetic
- patient refusal
- chronic opiods assumption
Sites / Locations
- Istituto Ortopedico G. Pini
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Spinal anesthesia
peripheral nerve block
Arm Description
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).
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)
Outcomes
Primary Outcome Measures
Time to home discharge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02384915
Brief Title
Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy
Official Title
Spinale Unilaterale o Blocco Nervoso Periferico Per le Artroscopie di Ginocchio in Day Surgery. Confronto Prospettico Randomizzato
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ASST Gaetano Pini-CTO
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal anesthesia
Arm Type
Experimental
Arm Description
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).
Arm Title
peripheral nerve block
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
prilocaine
Other Intervention Name(s)
prilotekal
Intervention Type
Drug
Intervention Name(s)
mepivacaine
Other Intervention Name(s)
carbocaine
Intervention Type
Procedure
Intervention Name(s)
Sciatic-femoral Nerve Block
Intervention Description
ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Intervention Description
intrathecal injection of 40 mg hyperbaric prilocaine
Intervention Type
Device
Intervention Name(s)
Sonoplex, Pajunk
Primary Outcome Measure Information:
Title
Time to home discharge
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
outpatients knee arthroscopy
Exclusion Criteria:
diabetes
allergy to local anesthetic
patient refusal
chronic opiods assumption
Facility Information:
Facility Name
Istituto Ortopedico G. Pini
City
Milan
State/Province
Milano
ZIP/Postal Code
20122
Country
Italy
12. IPD Sharing Statement
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Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy
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