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Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

Primary Purpose

Hallux Valgus

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Intraneural injection
Extraneural injection
Ropivacaine
PAJUNK SonoPlex 22G needle.
Sponsored by
ASST Gaetano Pini-CTO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istituto Ortopedico G. Pini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intraneural injection

extraneural injection

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
November 5, 2013
Last Updated
February 26, 2015
Sponsor
ASST Gaetano Pini-CTO
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1. Study Identification

Unique Protocol Identification Number
NCT01987128
Brief Title
Popliteal Sciatic Nerve Block: Intraneural or Extraneural?
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ASST Gaetano Pini-CTO

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraneural injection
Arm Type
Experimental
Arm 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.
Arm Title
extraneural injection
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Intraneural injection
Intervention Description
BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.
Intervention Type
Procedure
Intervention Name(s)
Extraneural injection
Intervention Description
BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Type
Device
Intervention Name(s)
PAJUNK SonoPlex 22G needle.
Primary Outcome Measure Information:
Title
onset time
Description
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.
Time Frame
every 2 minutes for a maximum of 30 minutes
Secondary Outcome Measure Information:
Title
success rate in each group
Description
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
Time Frame
at 30 minutes
Title
Nerve injuries
Description
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.
Time Frame
1, 5 weeks and at 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II Exclusion Criteria: Neurological diseases Diabetes Allergies to used drugs Chronic pain in treatment Electrophysiological alterations at time zero analysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianluca Cappelleri, MD
Organizational Affiliation
ASST Gaetano Pini-CTO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico G. Pini
City
Milan
State/Province
Milano
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27281720
Citation
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.
Results Reference
derived

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Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

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