Skip to main content
OpenTrials
Completed

NCT Number: NCT01987128

Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istituto Ortopedico G. Pini

Milan, Milano, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-II

Exclusion criteria

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

Treatment and study plan

Intraneural injection

Procedure

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

Extraneural injection

Procedure

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

Ropivacaine

Drug

PAJUNK SonoPlex 22G needle.

Device

Primary outcomes

  1. onset time

    Time frame: every 2 minutes for a maximum of 30 minutes

    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.

Secondary outcomes

  1. success rate in each group

    Time frame: at 30 minutes

    Success rate is described as the percentage of subjects with an onset time within 30 minutes in a group among all subjects treated in that group

  2. Nerve injuries

    Time frame: 1, 5 weeks and at 6 months after surgery

    Neurophysiological and clinic evaluation will be assessed either with clinical examination and electrophysiological tests by a neurophysiologist eventually evidencing any movement impairment or dysesthesia in the sciatic territory.

Sponsors and collaborators

Lead sponsor

ASST Gaetano Pini-CTO

Other

Registry information

Official study title

Blocco Del Nervo Sciatico al Poplite, Intraneurale o Extraneurale? Confronto Prospettico, Randomizzato in Cieco Tra la modalità di Iniezione di Anestetico Locale Per il Blocco Eco Guidato Del Nervo Sciatico al Poplite Nella Chirurgia Dell'Alluce Valgo

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 19, 2013
Registry last updated
Feb 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.