NCT01987128

Brief Summary

Aim of this study is to demonstrate the advantages of intraneural injection over extraneural injection in terms of onset and duration on peripheral block. In addition we will evaluate the frequency of possible adverse effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2013

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

November 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

November 5, 2013

Last Update Submit

February 26, 2015

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

  • onset time

    Pinprick test evaluation on sciatic nerve territory: With a 22G needle the blinded operator will assess sensitiveness to puncture and then assign a score every 2 minutes for 30 minutes. A score of 0 will describe no sensation to puncture, on the other hand a score of 1 will be assigned if sensation to puncture is still present. Evaluation of motor blockade: Plantar and dorsal flexion of the foot will be evaluated for motor blockade of sciatic nerve. A score of 1 will be assigned if foot movement is conserved, 2 if is impaired and 3 when disappears. Onset time is described as the time at which pinprick score turns to 0 and motor blockade score turns to 3.

    every 2 minutes for a maximum of 30 minutes

Secondary Outcomes (2)

  • success rate in each group

    at 30 minutes

  • Nerve injuries

    1, 5 weeks and at 6 months after surgery

Study Arms (2)

Intraneural injection

EXPERIMENTAL

All patients in the arm will receive a single intraneural injection of 12 ml Ropivacaine 1% BBraun, Germany, in the sciatic nerve under echographic guidance.

Procedure: Intraneural injectionDrug: RopivacaineDevice: PAJUNK SonoPlex 22G needle.

extraneural injection

ACTIVE COMPARATOR

All patients in the arm will receive a single extraneural injection of 12 ml Ropivacaine 1% BBraun, Germany, around the sciatic nerve under echographic guidance.

Procedure: Extraneural injectionDrug: RopivacaineDevice: PAJUNK SonoPlex 22G needle.

Interventions

Intraneural injectionPROCEDURE

BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.

Intraneural injection
Extraneural injectionPROCEDURE

BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.

extraneural injection
RopivacaineDRUG
Intraneural injectionextraneural injection
PAJUNK SonoPlex 22G needle.DEVICE
Intraneural injectionextraneural injection

Eligibility Criteria

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

You may qualify if:

  • ASA I-II

You may not qualify if:

  • Neurological diseases
  • Diabetes
  • Allergies to used drugs
  • Chronic pain in treatment
  • Electrophysiological alterations at time zero analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico G. Pini

Milan, Milano, 20122, Italy

Location

Related Publications (1)

  • Cappelleri G, Cedrati VL, Fedele LL, Gemma M, Camici L, Loiero M, Gallazzi MB, Cornaggia G. Effects of the Intraneural and Subparaneural Ultrasound-Guided Popliteal Sciatic Nerve Block: A Prospective, Randomized, Double-Blind Clinical and Electrophysiological Comparison. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):430-7. doi: 10.1097/AAP.0000000000000413.

    PMID: 27281720DERIVED

MeSH Terms

Conditions

Hallux Valgus

Interventions

RopivacaineNeedles

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEquipment and Supplies

Study Officials

  • Gianluca Cappelleri, MD

    ASST Gaetano Pini-CTO

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 19, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 27, 2015

Record last verified: 2015-02

Locations

IT(1)