Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

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

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.

Study Overview

• Status: Completed
• Conditions: Hallux Valgus
• Intervention / Treatment: Drug: Ropivacaine; Procedure: Intraneural injection; Device: PAJUNK SonoPlex 22G needle.; Procedure: Extraneural injection

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Milan, Milano, Italy, 20122
      • Istituto Ortopedico G. Pini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Ropivacaine; Procedure: Intraneural injection; BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.; Device: PAJUNK SonoPlex 22G needle.
ACTIVE_COMPARATOR: 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.	Drug: Ropivacaine; Device: PAJUNK SonoPlex 22G needle.; Procedure: Extraneural injection; BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: ASST Gaetano Pini-CTO

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (ESTIMATE): November 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 27, 2015
• Last Update Submitted That Met QC Criteria: February 26, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: IOGPGC04-13