Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

ASST Gaetano Pini-CTO

Status and phase: Completed; Phase 4

Conditions: Hallux Valgus

Treatments: Procedure: Intraneural injection; Procedure: Extraneural injection; Drug: Ropivacaine; Device: PAJUNK SonoPlex 22G needle.

Study type: Interventional

Funder types: Other

Identifiers

NCT01987128

IOGPGC04-13

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I-II

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Intraneural injection

Experimental group

Description:

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.

Treatment:

Procedure: Intraneural injection

Device: PAJUNK SonoPlex 22G needle.

Drug: Ropivacaine

extraneural injection

Active Comparator group

Description:

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.

Treatment:

Procedure: Extraneural injection

Device: PAJUNK SonoPlex 22G needle.

Drug: Ropivacaine