NCT02384915

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 8, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

February 20, 2015

Last Update Submit

May 7, 2015

Conditions

Knee Arthritis

Outcome Measures

Primary Outcomes (1)

  • Time to home discharge

    12 hours

Study Arms (2)

Spinal anesthesia

EXPERIMENTAL

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: prilocaineProcedure: Spinal anesthesia

peripheral nerve block

ACTIVE COMPARATOR

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: mepivacaineProcedure: Sciatic-femoral Nerve BlockDevice: Sonoplex, Pajunk

Interventions

prilocaineDRUG
Also known as: prilotekal
Spinal anesthesia
mepivacaineDRUG
Also known as: carbocaine
peripheral nerve block
Sciatic-femoral Nerve BlockPROCEDURE

ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve

peripheral nerve block
Spinal anesthesiaPROCEDURE

intrathecal injection of 40 mg hyperbaric prilocaine

Spinal anesthesia
Sonoplex, PajunkDEVICE
peripheral nerve block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • outpatients knee arthroscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico G. Pini

Milan, Milano, 20122, Italy

Location

MeSH Terms

Interventions

PrilocaineMepivacaineAnesthesia, Spinal

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 10, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 8, 2015

Record last verified: 2015-03

Locations

IT(1)