Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

Phase 4

Completed

• Conditions: Hallux Valgus
• Interventions: Procedure: Intraneural injection; Procedure: Extraneural injection; Drug: Ropivacaine; Device: PAJUNK SonoPlex 22G needle.

• Registration Number: NCT01987128
• Lead Sponsor: ASST Gaetano Pini-CTO

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-19
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraneural injection	Intraneural injection	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.
Intraneural injection	PAJUNK SonoPlex 22G needle.	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.
extraneural injection	Extraneural injection	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.
extraneural injection	PAJUNK SonoPlex 22G needle.	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.
Intraneural injection	Ropivacaine	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.
extraneural injection	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
onset time	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 Outcome Measures

Name	Time	Method
success rate in each group	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
Nerve injuries	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.

Trial Locations

Locations (1)

Istituto Ortopedico G. Pini; 🇮🇹 Milan, Milano, Italy