Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

Hallux Valgus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987128
• Other study ID #: IOGPGC04-13
• Status: Completed
• Phase: Phase 4
• First received: November 5, 2013
• Last updated: February 26, 2015
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: ASST Gaetano Pini-CTO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA I-II

Exclusion Criteria:

• Neurological diseases

• Diabetes

• Allergies to used drugs

• Chronic pain in treatment

• Electrophysiological alterations at time zero analysis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Procedure:
• Intraneural injection
BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.
• Extraneural injection
BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.

Drug:
• Ropivacaine

Device:
• PAJUNK SonoPlex 22G needle.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico G. Pini	Milan	Milano

Sponsors (1)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	success rate in each group	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	at 30 minutes	No
Secondary	Nerve injuries	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.	1, 5 weeks and at 6 months after surgery	Yes